Recall Z-1398-2023— Compass Health Brands (Corporate Office)
Class II · Ongoing
Class II FDA medical device recall by Compass Health Brands (Corporate Office), initiated 2023-03-07. It names one FDA 510(k) clearance: K192358. 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. Reason: 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.
- Recalling firm
- Compass Health Brands (Corporate Office)
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-07
- Firm location
- Middleburg Heights, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.