Cleared Traditional

Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1)

K231425 · Wuxi Jiajian Medical Instrument Co., Ltd. · Neurology

Mar 2024

Decision

315d

Days

Class 2

Risk

About This 510(k) Submission

K231425 is an FDA 510(k) clearance for the Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1), a Stimulator, Nerve, Transcutaneous, Over-the-counter (Class II — Special Controls, product code NUH), submitted by Wuxi Jiajian Medical Instrument Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on March 27, 2024, 315 days after receiving the submission on May 17, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K231425 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 17, 2023
Decision Date	March 27, 2024
Days to Decision	315 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

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