Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)

Stimulator, Nerve, Transcutaneous, For Pain Relief

Bozhou Rongjian Medical Appliance Co.,Ltd.

The following data is part of a premarket notification filed by Bozhou Rongjian Medical Appliance Co.,ltd. with the FDA for Transcutaneous Electrical Nerve Stimulator (model Rjtens-1).

Pre-market Notification Details

Device IDK220578
510k NumberK220578
Device Name:Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
ClassificationStimulator, Nerve, Transcutaneous, For Pain Relief
Applicant Bozhou Rongjian Medical Appliance Co.,Ltd. Jianghuai Supply Base, Zhongkai Group, Mengcheng County Bozhou,  CN 233500
ContactWu Zhifang
CorrespondentWu Zhifang
Bozhou Rongjian Medical Appliance Co.,Ltd. Jianghuai Supply Base, Zhongkai Group, Mengcheng County Bozhou,  CN 233500
Product CodeGZJ  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-02-28
Decision Date2022-05-25

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