510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230443Substantially Equivalent

TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)

Jiangxi Royall Smart Technology Co., Ltd., Ganzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230443 is the FDA 510(k) clearance record for TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04), a class II device, cleared for Jiangxi Royall Smart Technology Co., Ltd. on under FDA product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter). FDA's definition for product code NUH reads: "TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES". FDA records list one 510(k) clearance for Jiangxi Royall Smart Technology Co., Ltd. As of , FDA records show no recalls naming K230443.

Clearance record

Decision date
Received
(90 days to decision)
Product code
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Regulation
21 CFR 882.5890
Device class
Class II
Review panel
Neurology
Applicant
Jiangxi Royall Smart Technology Co., Ltd. Workshop 3#, Shangyou Lefeng Technology Co., Ltd.,, Ganzhou, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NUH

Trailing 12 months
10 clearances under product code NUH in the twelve months to October 2026, November 2025 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code NUH, trailing twelve months
MonthClearances
November 20253
December 20253
January 20260
February 20260
March 20261
April 20260
May 20260
June 20262
July 20260
August 20260
September 20261
October 20260