Compass Health Brands (Corporate Office) recalls REX (Recovery Exercise X-Trainer) Pressure Therapy System- USER Manual. Intended to temporarily relieve minor muscle ach

Recalled April 26, 2023 · FDA recall Z-1398-2023 · Compass Health Brands (Corporate Office)

Hazard

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 · FDA Class II

Units

30 units

Sold at

Worldwide distribution - US Nationwide and the country of Canada.

Description

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

Product

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

Manufacturer(s)

Compass Health Brands (Corporate Office)

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →