Cleared Traditional

Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)

K220578 · Bozhou Rongjian Medical Appliance Co., Ltd. · Neurology

May 2022

Decision

86d

Days

Class 2

Risk

About This 510(k) Submission

K220578 is an FDA 510(k) clearance for the Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1), a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II — Special Controls, product code GZJ), submitted by Bozhou Rongjian Medical Appliance Co., Ltd. (Bozhou, CN). The FDA issued a Cleared decision on May 25, 2022, 86 days after receiving the submission on February 28, 2022. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5890.

Submission Details

510(k) Number	K220578 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 28, 2022
Decision Date	May 25, 2022
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF