Tens & Ems Device (TU1080)— 510(k) K242787

Name: FDA 510(k) clearance K242787
Creator: U.S. Food and Drug Administration
Published: 2024-12-18

Substantially Equivalent

Changsha Anxiang Medical Technology Co., Ltd.

FDA 510(k) clearance K242787 for Tens & Ems Device (TU1080), Substantially Equivalent on 2024-12-18. Applicant: Changsha Anxiang Medical Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Changsha Anxiang Medical Technology Co., Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2024-09-16
Decision date: 2024-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changsha, CN

Download summary PDF View on FDA.gov ↗

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