Portable Electro-Stimulation Therapy Device— 510(k) K182020

Name: FDA 510(k) clearance K182020
Creator: U.S. Food and Drug Administration
Published: 2020-09-17

Substantially Equivalent

Guangzhou Longest Science & Technology Co., Ltd.

FDA 510(k) clearance K182020 for Portable Electro-Stimulation Therapy Device, Substantially Equivalent on 2020-09-17. Applicant: Guangzhou Longest Science & Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guangzhou Longest Science & Technology Co., Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2018-07-27
Decision date: 2020-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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