Cleared Special

OTC 4-Channel Rechargeable TENS Unit

K251429 · Changsha Anxiang Medical Technology Co., Ltd. · Physical Medicine

Aug 2025

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K251429 is an FDA 510(k) clearance for the OTC 4-Channel Rechargeable TENS Unit, 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 August 28, 2025, 112 days after receiving the submission on May 8, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K251429 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2025
Decision Date	August 28, 2025
Days to Decision	112 days
Submission Type	Special
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