Cleared Traditional

Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1)

K222879 · Wuxi Jiajian Medical Instrument Co., Ltd. · Neurology

Jan 2023

Decision

124d

Days

Class 2

Risk

About This 510(k) Submission

K222879 is an FDA 510(k) clearance for the Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1), a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Wuxi Jiajian Medical Instrument Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on January 24, 2023, 124 days after receiving the submission on September 22, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K222879 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 22, 2022
Decision Date	January 24, 2023
Days to Decision	124 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF