TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)— 510(k) K230443

Name: FDA 510(k) clearance K230443
Creator: U.S. Food and Drug Administration
Published: 2023-05-22

Substantially Equivalent

Jiangxi Royall Smart Technology Co., Ltd.

FDA 510(k) clearance K230443 for TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04), Substantially Equivalent on 2023-05-22. Applicant: Jiangxi Royall Smart Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Jiangxi Royall Smart Technology Co., Ltd.
Product code: Code NUH
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2023-02-21
Decision date: 2023-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ganzhou, CN

Download summary PDF View on FDA.gov ↗

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K253896 — TENS/EMS device (GUSE01)2026-03-04
K253305 — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034)2025-12-31
K251958 — VEINOPLUS Back2025-12-23

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