Device product
Brand Name: HOMEDICS Product Name: Air Compression Leg Massager Model/Catalog Number: SR-160HJ Product Description: Powered Inflatable Tube Massager used on the leg. The Air Compression Leg Massager is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in people who are in good health. The Air Compression Leg Massager simulates kneading and stroking of tissues by using an inflatable garment.
Z-2463-2025
Product summary
- Event
- Event 97333
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3705 US
- Official record key
device-enforcement:Z-2463-2025
Official wording
Reason: Regulatory documentation error and misleading color packaging claim.
Code information: UDI: 00031262108746 Product Code: IRP Lot # : All lots affected, however they do not present risk of harm. Expiration Date: 2 YEARS
Distribution pattern: Worldwide distribution - US Nationwide and the country of Canada.
Derived failure modes
-
Unknown
Regulatory documentation error and misleading color packaging claim.