OTC TENS & EMS Unit— 510(k) K243511

Name: FDA 510(k) clearance K243511
Creator: U.S. Food and Drug Administration
Published: 2025-02-10

Substantially Equivalent

Changsha Anxiang Medical Technology Co., Ltd.

FDA 510(k) clearance K243511 for OTC TENS & EMS Unit, Substantially Equivalent on 2025-02-10. 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: 2024-11-12
Decision date: 2025-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changsha, CN

Download summary PDF View on FDA.gov ↗

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More clearances from Changsha Anxiang Medical Technology Co., Ltd.

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K251429 — OTC 4-Channel Rechargeable TENS Unit2025-08-28
K251706 — TENS and EMS Unit2025-07-30
K251187 — 3 in 1 TENS UNIT (TC1241, TC2241, TS1241)2025-07-28
K250759 — 3 in 1 TENS UNIT2025-06-13
K243763 — Wireless TENS & EMS Unit2025-03-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.