FDA-Device2025-09-03Class II

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.

Zhejiang Luyao Electronics Technology Co., Ltd.
Hazard

Regulatory documentation error and misleading color packaging claim.

Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
3705 US
Manufactured in
Pingyang County, Wenzhou, China
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2463-2025

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