FDA-Device2023-04-26Class II
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
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
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
30 units
Manufactured in
6753 Engle Rd, N/A, Middleburg Heights, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1398-2023Don't want to check this manually?
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