TENS and EMS Stimulation (OTC)— 510(k) K230163

Substantially Equivalent

Changsha Yuwen Medical Equipment Co., Ltd.

FDA 510(k) clearance K230163 for TENS and EMS Stimulation (OTC), Substantially Equivalent on 2023-03-20. Applicant: Changsha Yuwen Medical Equipment Co., Ltd..

Clearance details

Applicant: Changsha Yuwen Medical Equipment Co., Ltd.
Product code: Code NUH
Advisory panel: Neurology
Date received: 2023-01-20
Decision date: 2023-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changsha, CN

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