Cleared Traditional

3 in 1 TENS UNIT (TC1241, TC2241, TS1241)

K251187 · Changsha Anxiang Medical Technology Co., Ltd. · Physical Medicine

Jul 2025

Decision

102d

Days

Class 2

Risk

About This 510(k) Submission

K251187 is an FDA 510(k) clearance for the 3 in 1 TENS UNIT (TC1241, TC2241, TS1241), a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Changsha Anxiang Medical Technology Co., Ltd. (Changsha, CN). The FDA issued a Cleared decision on July 28, 2025, 102 days after receiving the submission on April 17, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K251187 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 17, 2025
Decision Date	July 28, 2025
Days to Decision	102 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement

Device Classification

Product Code	NUH — Stimulator, Nerve, Transcutaneous, Over-the-counter
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.5890
Definition	Temporary Relief Of Pain Due To Sore/aching Muscles