Brand
Compass Health Brands (Corporate Office)
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Compass Health Brands (Corporate Office) and translate it into plain English — free weekly digest, optional same-day alerts.
- 2023-04-26FDA-DeviceClass IIREX (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
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