Recall Z-2463-2025— Zhejiang Luyao Electronics Technology Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by Zhejiang Luyao Electronics Technology Co., Ltd., initiated 2025-01-17. It names one FDA 510(k) clearance: K222949. 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.. Reason: Regulatory documentation error and misleading color packaging claim..
- Recalling firm
- Zhejiang Luyao Electronics Technology Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2025-01-17
- Firm location
- Wenzhou, China
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
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.
Reason for recall
Regulatory documentation error and misleading color packaging claim.
Data sourced from openFDA. This site is unofficial and independent of the FDA.