EMS Sculpt Machine— 510(k) K232982

Name: FDA 510(k) clearance K232982
Creator: U.S. Food and Drug Administration
Published: 2024-11-25

Substantially Equivalent

Shandong Huamei Technology Co., Ltd.

FDA 510(k) clearance K232982 for EMS Sculpt Machine, Substantially Equivalent on 2024-11-25. Applicant: Shandong Huamei Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shandong Huamei Technology Co., Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2023-09-22
Decision date: 2024-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wei Fang, CN

Download summary PDF View on FDA.gov ↗

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