Sunrise Medical, Inc.
Somerset, PA, US
Sunrise Medical, Inc. appears in FDA device records in Somerset, PA. FDA records list 45 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 30 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Sunrise Medical, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- DeVilbiss Healthcare LLC.registration, 510(k), enforcement report, recall
- Sunrise Medical (Us), LLCregistration, 510(k), enforcement report, recall
- Sunrise Medical HHG Inc. dba DeVilbiss Healthcarerecall
510(k) clearance history
FDA records hold 45 510(k) clearances for Sunrise Medical, Inc. between 1992 and 2026. The busiest year on record is 1998, with 7. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| 1997 | 2 |
| 1998 | 7 |
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 3 |
| 2006 | 3 |
| 2007 | 3 |
| 2008 | 2 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 3 |
| 2015 | 1 |
| 2016 | 2 |
| 2018 | 2 |
| 2022 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253549 | DeVilbiss 5 Liter Oxygen Concentrator (555) | CAW | Substantially Equivalent | |
| K250805 | DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) | CAW | Substantially Equivalent | |
| K220213 | Empulse R90 | ITI | Substantially Equivalent | |
| K172648 | Drive DeVilbiss iGo 2 Portable Oxygen Concentrator | CAW | Substantially Equivalent | |
| K172384 | Quickie(r) Q700-UP M | IPL | Substantially Equivalent | |
| K160031 | Quickie Pulse (Models 6BC, 6SC, 6CC, 5BC, 5CC, 6MPC) and Zippie ZM-310 (Models BC, SC) | ITI | Substantially Equivalent | |
| K152810 | DeVilbiss DV6WM Wireless Modem | BZD | Substantially Equivalent | |
| K143677 | DeVilbiss Intellipap2/DeVilbiss BLUE | BZD | Substantially Equivalent | |
| K142457 | Quickie, Zippie | ITI | Substantially Equivalent | |
| K140880 | DEVILBISS SMARTLINK II SYSTEM | BZD | Substantially Equivalent | |
| K133855 | BREEZY ELEGANCE | IOR | Substantially Equivalent | |
| K123975 | QUICKIE & ZIPPIE SERIES | IOR | Substantially Equivalent | |
| K112220 | DEVILBISS INTELLIPAP / SLEEPCUBE AUTO BILEVEL | BZD | Substantially Equivalent | |
| K093070 | DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES | MNS | Substantially Equivalent | |
| K091919 | DEVILBISS INTELLIPAP/SLEEPCUBE BILEVEL S/ST | BZD | Substantially Equivalent | |
| K082209 | DEVILBISS DV5M SMARTLINK SYSTEM | BZD | Substantially Equivalent | |
| K081468 | DEVILBISS PORTABLE OXYGEN CONCENTRATOR, 306 SERIES | CAW | Substantially Equivalent | |
| K071397 | DEVILBISS 5 LITER COMPACT OXYGEN CONCENTRATOR, MODEL 525 SERIES | CAW | Substantially Equivalent | |
| K072153 | QUICKIE QX MANUAL FOLDING WHEELCHAIR | IOR | Substantially Equivalent | |
| K071689 | DEVILBISS INTELLIPAP MODEL DV 5 SERIES | BZD | Substantially Equivalent | |
| K062701 | QUICKIE RHAPSODY, MWD SERIES II POWER WHEELCHAIR | ITI | Substantially Equivalent | |
| K060531 | QUICKIE RHYTHM & GROOVE SERIES POWER WHEELCHAIRS W/QUICKIE DELPHI CONTROLS | ITI | Substantially Equivalent | |
| K053240 | DEVILBISS OXYGEN CYLINDER FILLING SYSTEM, 535 SERIES | CAW | Substantially Equivalent | |
| K043435 | QUICKIE INTERCHANGE FWD W/LIFT POWER WHEELCHAIR | ITI | Substantially Equivalent | |
| K043282 | DEVILBISS AUTOADJUST, MODEL 9054 SERIES | BZD | Substantially Equivalent | |
| K042455 | DEVILBISS NASAL CPAP MASK, 9354 SERIES | BZD | Substantially Equivalent | |
| K032056 | BILEVEL CPAP, MODEL 9055 SERIES | BZD | Substantially Equivalent | |
| K031289 | QUICKIE FREESTYLE POWER WHEELCHAIR, MODEL G-424 | ITI | Substantially Equivalent | |
| K020932 | DEVILBISS PULMO-AIDE COMPACT COMPRESSOR | CAF | Substantially Equivalent | |
| K011268 | BREEZY WHEELCHAIR, MODEL 300 | IOR | Substantially Equivalent | |
| K010917 | POWER TILT AND RECLINE SYSTEM | ITI | Substantially Equivalent | |
| K001491 | QUICKIE 2 POWER ASSIST WHEELCHAIR | ITI | Substantially Equivalent | |
| K981885 | SUNRISE SCOOTER SERIES, MODEL UNASSIGNED, 3 WHEEL STANDARD MODEL, 3 WHEEL MID RANGE MODEL, 3 WHEEL HIGH END MODEL, 4 WHE | INI | Substantially Equivalent | |
| K983677 | QUICKIE G SERIES, MODEL G-424 | ITI | Substantially Equivalent | |
| K983520 | BREATH CONTROL (BREATH ACTUATOR), SENSITOUCH BREATH CONTROL, HEAD ARRAY (SWITCH HEAD CONTROL), TRI-SWITCH HEAD ARRAY, HD | ITI | Substantially Equivalent | |
| K981462 | QUICKIE P100 SERIES, QUICKIE P200 SERIES, QUICKIE P300 SERIES, MODELS P100,P110,P120,P190,P190R,P500,P200,P210,P320,P300 | ITI | Substantially Equivalent | |
| K983639 | ZIPPIE GS, MODEL # EIZGS | IOR | Substantially Equivalent | |
| K982989 | QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR | IOR | Substantially Equivalent | |
| K974820 | BREEZY SERIES | IOR | Substantially Equivalent | |
| K973673 | QUICKIE ZIPPIE SERIES, QUICKIE BREEZY SERIES, QUICK FOLDING SERIES, QUICKIE RIGID SERIES | IOR | Substantially Equivalent | |
| K972797 | TOOL-LESS WHEEL CHAIR | IOR | Substantially Equivalent | |
| K952641 | QUICKIE TSR | IOR | Substantially Equivalent | |
| K944423 | POWER RECLINER | ITI | Substantially Equivalent for Some Indications | |
| K925112 | BIO CLINIC UNDER PATIENT SCALE | FRN | Substantially Equivalent | |
| K922205 | BIO THERAPY PLUS | FNM | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2515872 | 2515872 | DeVilbiss Healthcare LLC. | 100 Devilbiss Dr, SOMERSET, PA 15501 US | 2026 | |
| 2937137 | 2937137 | SUNRISE MEDICAL (US) LLC | 3 E River Park Pl E, FRESNO, CA 93720 US | 2026 | and 11 more, listed in full below |
| 3019677893 | 3019677893 | Sunrise Medical (US) LLC | 12002 Volunteer Blvd, Mount Juliet, TN 37122 US | 2026 | and 11 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNOAccessories, Wheelchair
- ILSAdaptor, Hygiene
- ILTAdaptor, Recreational
- IKXAid, Transfer
- JCXApparatus, Suction, Ward Use, Portable, Ac-Powered
- IMLArmrest, Wheelchair
- IQBBelt, Wheelchair
- IMXBoard, Lap, Wheelchair
- KDQBottle, Collection, Vacuum
- IMWBrake, Extension, Wheelchair
- INMChair, With Casters
- KNNComponents, Wheelchair
- BTICompressor, Air, Portable
- KICCushion, Flotation
- IMPCushion, Wheelchair
- IMRDevice, Anti-Tip, Wheelchair
- IMMFootrest, Wheelchair
- CAWGenerator, Oxygen, Portable
- IMOHandrim, Wheelchair
- IMZHolder, Crutch And Cane, Wheelchair
- FNMMattress, Air Flotation, Alternating Pressure
- CAFNebulizer (Direct Patient Interface)
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- FMPProtector, Skin Pressure
- FRNPump, Infusion
- IMSSupport, Head And Trunk, Wheelchair
- INIVehicle, Motorized 3-Wheeled
- MNSVentilator, Continuous, Non-Life-Supporting
- BZDVentilator, Non-Continuous (Respirator)
- ITJWalker, Mechanical
- IORWheelchair, Mechanical
- ITIWheelchair, Powered
- IPLWheelchair, Standup
Recall records
Showing 25 of 30| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1558-2023 | DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR, Model Numbers 1025DS, 1025UK, 1025KS, and 1025KS-AR | The instruction manual is being replaced with an updated version that is in alignment with labeling requirements specified in the IEC-60101-1 standard. | Class II | Open, Classified | |
| Z-0724-2023 | DeVilbiss, 525 5-liter Oxygen Concentrator Models 525DS, 525DS-Q | The firm has received complaints of the device becoming hot. The firm has updated the user manual to include warnings that applied parts in contact with the patient may in some situations exceed 41 degrees Celsius (105.8 degrees Fahrenheit), clarification on expected service life, and the need for maintenance to certain components. | Class II | Open, Classified | |
| Z-0229-2023 | 125 series iGO2 Portable Oxygen Concentrator-indicated for the administration of supplemental oxygen. Models: 125D, 125D-XB | An unapproved adhesive used to manufacture the accumulator tank sub assembly (a part of the patient gas pathway) | Class II | Open, Classified | |
| Z-2158-2021 | Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds. | The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury. | Class II | Terminated | |
| Z-2157-2021 | Zippie Voyage, early intervention stroller - Product Usage: is manually operated by a caregiver for purposes of assisting a disabled person while providing supportive elements for assisted transportation and seating for a child or small adult not to exceed 75 pounds. | The seating system unexpectedly detached, which resulted in the seating system falling to the ground, causing injury. | Class II | Terminated | |
| Z-1947-2020 | Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is controlled by Power Module RNET 120A Expandable (Item No.: 250ER10, Part No.: 123966). | Due to programming errors in the Controller, an increase in the set motor parameters can be made by the end user beyond tested safe limits. | Class II | Terminated | |
| Z-2290-2016 | Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's intended use is to provide mobility to persons limited to a sitting position. | There is an observed failure of the backrest bracket which can fatigue over the life time of the product. When this occurs there is the possibility of the bracket fracturing causing the backrest to detach from the chair frame. | Class II | Terminated | |
| Z-2246-2016 | DeVilbiss Model 7305P-D Powered Suction Unit | A small percentage of units of 7305 Series Vacu-Aide Suction Units are experiencing premature failure during operation. | Class II | Terminated | |
| Z-2467-2015 | Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position. | Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant. | Class II | Terminated | |
| Z-2466-2015 | Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position. | Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant. | Class II | Terminated | |
| Z-1020-2015 | Quickie Q7 Adult Rigid Wheelchair Model EIR4. | There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs. | Class II | Terminated | |
| Z-1019-2015 | Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1. | There is the potential for the height adjustable handle to dislodge due to failing locking mechanisms on specific identified chairs. | Class II | Terminated | |
| Z-1949-2014 | DeVilbiss Model DV5x Series CPAP units. For use in treating Obstructive Sleep Apnea (OSA) by means of application of positive air pressure. Used in home and clinical environments. | A limited number of DV5x Series CPAP units were manufactured and shipped without the serial number programmed into the unit, causing the unit serial number on LCD display to appear as "RUN-TEST". | Class III | Terminated | |
| Z-0453-2014 | Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting. | There is a remote possibility for the plastic latch to deform over the lifetime of use. When this happens there is the possibility for the seat to become dislodged from the base. And when not using the positioning strap, there is a risk that the occupant could slide out of the seat and sustain injury. | Class II | Terminated | |
| Z-2319-2013 | DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order. | End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable. | Class II | Terminated | |
| Z-2113-2012 | Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3), GTi (EIT4) and Zippie Zone (EIRZ1). Product Usage: To empower physically challenged persons by providing a means of mobility. This includes temporary and permanent conditions. | Reports of injury when the Padded Swing Away Armrest is used for full body weight. Owner's manual states that armrest is only designed for resting of forearm. | Class II | Terminated | |
| Z-1103-2012 | Sunrise Medical Zippie TS wheelchair To empower physically challenged person by providing a means or mobility. | One Zippie TS Wheelchair was made per customer order was shipped with transit brackets for use a seat in a motor vehicle, however the chair was not configured with a back tested seat for motor vehicle use. | Terminated | ||
| Z-2990-2011 | DeVilbiss Model DV5x Series CPAP with Heated Humidifier Device is intended to treat Obstructive Sleep Apnea (OSA) in patients weighing 30 Kg and above. The device creates a positive pressure in the patient's airway to prevent collapse of the airway while the patient is sleeping. The heated humidifier provides additional humidity to the air supplied to the patient. The heated humidifier has a removable water chamber for filling with water and ease of cleaning. | Some units were manufactured with a defective humidifier chamber o-ring. Unit could leak, allowing water to escape during use, causing damage to furniture. | Terminated | ||
| Z-0831-2011 | Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is manufactured and distributed by Sunrise Medical, Inc. Fresno, CA Intended to provide mobility to persons restricted to a sitting position and are unable to transfer from their wheelchairs when traveling in motor vehicles, the wheelchair must serve as a vehicle seat. | The stabilizer bar was inadvertently omitted during the manufacturing process. | Terminated | ||
| Z-0617-2009 | DeVilbiss Model 515A Oxygen Concentrator Intended to provide supplemental low flow oxygen therapy. These devices can be used in homes, nursing homes, and patient care facilities. | potential for sieve beds to have been incorrectly assembled | Terminated | ||
| Z-0863-2009 | DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compressed air-powered suction pump. The device may include a microbial filter. | Improper suction: Regulator knob does not turn properly which can affect the suction level. | Terminated | ||
| Z-1532-2008 | Quickie Groove Power Wheelchair with QC (non-expandable) electronics, Model number EIPW13. | Product experiences a longer than expected stopping distance, which may cause injury to the user, objects, or the chair itself. | Terminated | ||
| Z-1531-2008 | Quickie Rhythm Power Wheelchair with QC (non-expandable) electronics, Model number EIPW10 | Product experiences a longer than expected stopping distance, which may cause injury to the user, objects, or the chair itself. | Terminated | ||
| Z-1163-2007 | Sunrise Medical Quickie Power Wheelchairs: Three models -Rhythm, Groove, and Zippy Z-Bop (with Quickie IQ Enhanced Displays) | The wire harness connected to the display housing (Quickie IQ Enhanced Displays) may separate and cause sparks from a short circuit. | Terminated | ||
| Z-0732-2007 | 535D-X CF Continuous Flow Cylinder | Cylinder could lose oxygen at high pressure after the filling process | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain