Air Compression Leg Massager (model: EMK-701)— 510(k) K222991

Name: FDA 510(k) clearance K222991
Creator: U.S. Food and Drug Administration
Published: 2023-03-15

Substantially Equivalent

Xiamen Emoka Health Science & Technology Co., Ltd.

FDA 510(k) clearance K222991 for Air Compression Leg Massager (model: EMK-701), Substantially Equivalent on 2023-03-15. Applicant: Xiamen Emoka Health Science & Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Xiamen Emoka Health Science & Technology Co., Ltd.
Product code: Code IRP
Device class: Class 2
Regulation: 21 CFR 890.5650
Advisory panel: Physical Medicine
Date received: 2022-09-28
Decision date: 2023-03-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Xiamen, CN

Download summary PDF View on FDA.gov ↗

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