Joerns Healthcare
Arlington, TX, US
Joerns Healthcare appears in FDA device records in Arlington, TX. FDA records list 2 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 8 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Joerns Healthcare 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.
- Sunrise Medical CCG, Inc.recall
510(k) clearance history
FDA records hold 2 510(k) clearances for Joerns Healthcare between 1995 and 1997. The busiest year on record is 1995, with 1. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K964926 | BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC | ILJ | Substantially Equivalent | |
| K951735 | JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL | FNL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3009402404 | 3009402404 | Joerns Healthcare | 2100 Design Rd, Arlington, TX 76014 US | 2026 | |
| 3012392312 | 3012392312 | Joerns Healthcare | 2430 Whitehall Park Dr Ste 700, Charlotte, NC 28273 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- OSIBariatric Bed
- ILJBath, Hydro-Massage
- FNLBed, Ac-Powered Adjustable Hospital
- FNJBed, Manual
- LLIBed, Therapeutic, Ac-Powered, Adjustable Home-Use
- BYNChair, Posture, For Cardiac And Pulmonary Treatment
- FMWCover, Mattress (Medical Purposes)
- FSALift, Patient, Non-Ac-Powered
- FNMMattress, Air Flotation, Alternating Pressure
- IKYMattress, Flotation Therapy, Non-Powered
- MRIOrthosis, Truncal/Orthosis, Limb
- FMPProtector, Skin Pressure
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2034-2018 | ProCair Mattress: (a) PROCAIR PLUS 42X80, MATERIAL NUMBER 222-4280 (b) PROCAIR PLUS 36X80, MATERIAL NUMBER 222-3680 (c) PROCAIR PLUS 84" MATTRESS, MATERIAL NUMBER 222-6384 Product Usage: Non powered flotation therapy mattress. The device is intended to treat or prevent decubitus ulcers (bed sores). | Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a Joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells. | Class II | Terminated | |
| Z-2033-2018 | P.R.O. Matt: (a) PROMATT PLUS 36 X 76 MATRESS, NYLON, MATERIAL NUMBER PMP3676NZBA (b) PROMATT PLUS 84" MATRESS, NYLON, MATERIAL NUMBER PMP3684NZBA (c) PROMATT PLUS W/SIDEWALLS, 42X80, MATERIAL NUMBER PMS4280NZBA (d) PROMATT PLUS 36IN MATRESS, MATERIAL NUMBER PMP3680NZBA (e) PROMATT WITH SIDEWALLS ASSEMBLY, MATERIAL NUMBER PMS3680NZBA (f) PROMATT PLUS 80IN MATRESS, STRETCH, MATERIAL NUMBER PMP3680SZBA (g) PROMATT PLUS 42IN MATRESS, MATERIAL NUMBER PMP4280NZBA (h) PROMATT PLUS 85cm MATRESS, DURATUB, MATERIAL NUMBER PMPE3480SZBADT Product Usage: Non powered flotation therapy mattress. The device is intended to treat or prevent decubitus ulcers (bed sores). | Joerns Healthcare has identified a potential issue with some of the P.R.O. Matt and ProCair Mattresses. For the identified serial number range of P.R.O. Matt and ProCair Mattresses incorrect connectors (part #s 206-0401 & 206-0405) were provided by a Joerns supplier without the required internal shutoff valves, these shutoff valves prevent air from escaping from the mattress air cells. | Class II | Terminated | |
| Z-0151-2015 | Joerns EasyCare Bed Product Usage: The AC-powered adjustable hospital bed is a device intended for medical purposes. The bed includes a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. | The Easy-Care Care-Lock feature installed at the foot of the bed may potentially fail to stay engaged (locked) after the Care-Lock System has been engaged by stepping on the red (locked) pedal. | Class II | Terminated | |
| Z-0727-2007 | Sunrise Medical-Hoyer Advance Patient Lifts (Portable and Folding Patient Lift) Sunrise Medical, Inc. | Unapproved Design Change (by base supplier) consisting of a reduction in the number of mast-to-base welds (from four welds to two welds). | Terminated | ||
| Z-0904-06 | Hoyer Hydraulic Patient Lifters model C-CB-L2, C-HLA, C-HLA-2, HML-400, C-HLA-2T and C-HLA-1. Distributed by Sunrise Medical, Inc. 7477 East Dry Creek Parkway, Longmont, CO 80503 USA. | A field correction is being conducted on select models of Hoyer Patient Lifts because of hydraulic jack problems that have resulted in patient injury. The possibility exists that the mounting stud located in the bottom of the hydraulic jack could become loose allowing the jack to disengage from the mast of the lift. | Terminated | ||
| Z-0016-2007 | Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA. | The control box used in the actuator systems appears to have a potential to become stuck in one position resulting a non-functioning bed. | Terminated | ||
| Z-1412-06 | Joerns Easy Care 2003 bed, Model B684; Joerns Easy Care 2003 DC bed, Model B684DC; Joerns Easy Care 2100, Model B694 AC-powered adjustable Hospital Beds | Malfunction- the Easy care drive system performance, controlling back and knee section angle adjustment, as well as, bed height adjustment could become non-functional . | Terminated | ||
| Z-1411-06 | Joerns Easy Care 2000, Model B784, Manual adjustable Hospital Bed | Malfunction- the Easy care drive system performance, controlling back and knee section angle adjustment, as well as, bed height adjustment could become non-functional . | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain