StimOnTM Pain Relief System (GM2439)— 510(k) K213802

Name: FDA 510(k) clearance K213802
Creator: U.S. Food and Drug Administration
Published: 2022-08-26

Substantially Equivalent

Gimer Medical Co., Ltd.

FDA 510(k) clearance K213802 for StimOnTM Pain Relief System (GM2439), Substantially Equivalent on 2022-08-26. Applicant: Gimer Medical Co., Ltd.. Device class: 2.

Clearance details

Applicant: Gimer Medical Co., Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2021-12-06
Decision date: 2022-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Taipei City, TW

Download summary PDF View on FDA.gov ↗

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