Air Compression Leg Massager (Model: LY-670D)— 510(k) K222949

Name: FDA 510(k) clearance K222949
Creator: U.S. Food and Drug Administration
Published: 2022-12-22

Substantially Equivalent

Zhejiang Luyao Electronics Technology Co., Ltd.

FDA 510(k) clearance K222949 for Air Compression Leg Massager (Model: LY-670D), Substantially Equivalent on 2022-12-22. Applicant: Zhejiang Luyao Electronics Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Zhejiang Luyao Electronics Technology Co., Ltd.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2022-09-27
Decision date: 2022-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wenzhou, CN

Download summary PDF View on FDA.gov ↗

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Recalls naming K222949

K-number listed on FDA's recall record

Z-2463-2025 — 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.Class II·Ongoing·Zhejiang Luyao Electronics Technology Co., Ltd.·20250117

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K222949.

Data sourced from openFDA. This site is unofficial and independent of the FDA.