TENS and EMS Stimulation (OTC)— 510(k) K230174

Name: FDA 510(k) clearance K230174
Creator: U.S. Food and Drug Administration
Published: 2023-03-20

Substantially Equivalent

Changsha Yuwen Medical Equipment Co., Ltd.

FDA 510(k) clearance K230174 for TENS and EMS Stimulation (OTC), Substantially Equivalent on 2023-03-20. Applicant: Changsha Yuwen Medical Equipment Co., Ltd.. Device class: 2.

Clearance details

Applicant: Changsha Yuwen Medical Equipment Co., Ltd.
Product code: Code NUH
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2023-01-20
Decision date: 2023-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changsha, CN

Download summary PDF View on FDA.gov ↗

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More clearances from Changsha Yuwen Medical Equipment Co., Ltd.

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K230164 — TENS and EMS Stimulation (OTC)2023-04-10
K230163 — TENS and EMS Stimulation (OTC)2023-03-20
K212184 — TENS and EMS Stimulation (OTC)2022-04-01

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