Compass Health Brands (Corporate Office)
Middleburg Heights, OH, US
COMPASS HEALTH BRANDS (CORPORATE OFFICE) appears in FDA device records in Middleburg Heights, OH. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show 9 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012316249 | 3012316249 | COMPASS HEALTH BRANDS (CORPORATE OFFICE) | 6753 Engle Rd, Middleburg Heights, OH 44130 US | 2026 | and 109 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- ILZAccessories, Traction
- ILDAdaptor, Dressing
- ILSAdaptor, Hygiene
- ILTAdaptor, Recreational
- IKXAid, Transfer
- GCYApparatus, Suction, Single Patient Use, Portable, Nonpowered
- HSTApparatus, Traction, Non-Powered
- INBAttachment, Commode, Wheelchair
- FNLBed, Ac-Powered Adjustable Hospital
- FNJBed, Manual
- FOBBedpan
- FPFBottle, Hot/Cold Water
- IKDCable, Electrode
- CATCannula, Nasal, Oxygen
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- BXJClip, Nose
- BTICompressor, Air, Portable
- BZAConnector, Airway (Extension)
- FLLContinuous Measurement Thermometer
- FMWCover, Mattress (Medical Purposes)
- IMPCushion, Wheelchair
- HCCDevice, Biofeedback
- CBHDevice, Fixation, Tracheal Tube
- EGJDevice, Iontophoresis, Other Uses
- IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- BYHDrain, Tee (Water Trap)
- GXYElectrode, Cutaneous
- BXBExerciser, Powered
- CAHFilter, Bacterial, Breathing-Circuit
- IMMFootrest, Wheelchair
- CAWGenerator, Oxygen, Portable
- BTTHumidifier, Respiratory Gas, (Direct Patient Interface)
- ILYLamp, Infrared, Therapeutic Heating
- FSALift, Patient, Non-Ac-Powered
- BYGMask, Oxygen
- FNMMattress, Air Flotation, Alternating Pressure
- IKYMattress, Flotation Therapy, Non-Powered
- GYBMedia, Electroconductive
- CAFNebulizer (Direct Patient Interface)
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- IMAPack, Heat, Moist
- IMDPack, Hot Or Cold, Disposable
- IMEPack, Hot Or Cold, Reusable
- EWDProtector, Hearing (Insert)
- FMPProtector, Skin Pressure
- HGXPump, Breast, Powered
- CANRegulator, Pressure, Gas Cylinder
- BZOSet, Tubing And Support, Ventilator (W Harness)
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- ILHSplint, Hand, And Components
- FOXStand, Infusion
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- GZIStimulator, Neuromuscular, External Functional
- IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
- BTKStrap, Head, Gas Mask
- BYXTubing, Pressure And Accessories
- IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat
- FNPUrinal
- ILCUtensil, Eating
- BZDVentilator, Non-Continuous (Respirator)
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1398-2023 | REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas. Models: DVTREX-U and DVTREX -L | Error in the Introduction section of the user manual that indicates the device may be used for the prevention of deep vein thrombosis (DVT). Marketed without a 510k for this indication | Class II | Open, Classified | |
| Z-0510-2022 | Voyager Rollator-intended as a mechanical walker Model Number: RLEU10xx (RLEU10BL, RLEU10PK, RLEU10WT) RLEU10BL Voyager Rollator Cobalt Blue UPC: 815067078066; RLEU10PK Voyager Rollator Rose Gold UPC: 815067078073; RLEU10WT Voyager Rollator Ice Palace UPC: 815067078080 | Wheel spoke may crack causing the wheel to separate from the axle may result in patient injuries, including bruising and lacerations requiring stitches. | Class II | Open, Classified | |
| Z-1348-2019 | MediPress pneumatic compression system Full Arm (Short)-Segmental Gradient, Model #6104S-S | Product design change did not receive proper premarket clearance and lacks a 510 (k) | Class II | Terminated | |
| Z-1347-2019 | MediPress pneumatic compression system Full Leg (Short)-Segmental Gradient, Model #6103S-S | Product design change did not receive proper premarket clearance and lacks a 510 (k) | Class II | Terminated | |
| Z-1346-2019 | MediPress pneumatic compression system Full Leg (Long)-Segmental Gradient, Model #6103L-S | Product design change did not receive proper premarket clearance and lacks a 510 (k) | Class II | Terminated | |
| Z-1345-2019 | MediPress pneumatic compression system Full Arm (Medium)-Segmental Gradient, Model #6104M-S | Product design change did not receive proper premarket clearance and lacks a 510 (k) | Class II | Terminated | |
| Z-1344-2019 | MediPress pneumatic compression system Full Leg (Medium)-Segmental Gradient, Model #6103M-S | Product design change did not receive proper premarket clearance and lacks a 510 (k) | Class II | Terminated | |
| Z-1343-2019 | MediPress pneumatic compression system, Half Leg-Segmental Gradient, Model #6102-S | Product design change did not receive proper premarket clearance and lacks a 510 (k) | Class II | Terminated | |
| Z-2741-2018 | CPAP Mask Cushion, Model Nos. PB781S, PB781M, PB781L, 781S, 781M and 781L Product Usage: A CPAP mask is attached to an end user s face and a CPAP machine, to treat end users with sleep apnea. The replacement cushion is a non-durable component that requires replacement every 3 - 6 months. The cushion is used for both comfort and to provide a seal between the face and the mask. | A May 2015 design change in the cushion seal replacement part and accompanying elbow replacement part resulted in incompatibility of the new cushion seal with the previous design of the elbow. Use of the new cushion seal with the previous design elbow could lead to unacceptable CO2 porting. As there was no model number change for this design change, customers may not be aware of the incompatibility. | Class I | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain