Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01— 510(k) K212377

Name: FDA 510(k) clearance K212377
Creator: U.S. Food and Drug Administration
Published: 2022-04-15

Substantially Equivalent

Ningbo Medkinetic Medical Device Co., Ltd.

FDA 510(k) clearance K212377 for Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01, Substantially Equivalent on 2022-04-15. Applicant: Ningbo Medkinetic Medical Device Co., Ltd.. Device class: 2.

Clearance details

Applicant: Ningbo Medkinetic Medical Device Co., Ltd.
Product code: Code NUH
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2021-08-02
Decision date: 2022-04-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ningbo, CN

Download summary PDF View on FDA.gov ↗

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