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
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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