Pain Therapy Device— 510(k) K202638

Name: FDA 510(k) clearance K202638
Creator: U.S. Food and Drug Administration
Published: 2021-07-15

Substantially Equivalent

Guangzhou Xinbo Electronic Co., Ltd.

FDA 510(k) clearance K202638 for Pain Therapy Device, Substantially Equivalent on 2021-07-15. Applicant: Guangzhou Xinbo Electronic Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guangzhou Xinbo Electronic Co., Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2020-09-11
Decision date: 2021-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, CN

Download summary PDF View on FDA.gov ↗

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K230711 — Pain Therapy Device(Model: P.T.S-X)2024-05-16
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