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U.S. Department of Health and Human Services

Class 2 Device Recall HOMEDICS

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 Class 2 Device Recall HOMEDICSsee related information
Date Initiated by FirmJanuary 17, 2025
Date PostedAugust 28, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2463-2025
Recall Event ID 97333
510(K)NumberK222949 
Product Classification Massager, powered inflatable tube - Product Code IRP
ProductBrand 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.
Code Information UDI: 00031262108746 Product Code: IRP Lot # : All lots affected, however they do not present risk of harm. Expiration Date: 2 YEARS
Recalling Firm/
Manufacturer		 Zhejiang Luyao Electronics Technology Co., Ltd.
Pingyang County
Wenzhou China
For Additional Information ContactJoyce Lin
+86-577-6377500
Manufacturer Reason
for Recall		Regulatory documentation error and misleading color packaging claim.
FDA Determined
Cause 2		Error in labeling
ActionOn January 17, 2025, Luyao notified their US distributor about the product recall. The company has declared permanent cessation of production and sales for the affected massager. Firm is collecting unsold inventory from warehouses.
Quantity in Commerce3705 US
DistributionWorldwide distribution - US Nationwide and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = IRP
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