Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)— 510(k) K220578

Name: FDA 510(k) clearance K220578
Creator: U.S. Food and Drug Administration
Published: 2022-05-25

Substantially Equivalent

Bozhou Rongjian Medical Appliance Co., Ltd.

FDA 510(k) clearance K220578 for Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1), Substantially Equivalent on 2022-05-25. Applicant: Bozhou Rongjian Medical Appliance Co., Ltd.. Device class: 2.

Clearance details

Applicant: Bozhou Rongjian Medical Appliance Co., Ltd.
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2022-02-28
Decision date: 2022-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bozhou, CN

Download summary PDF View on FDA.gov ↗

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