DR-HO's Back Pain Relief System Pro (Models BPRS-I And BPRS-II)

Stimulator, Nerve, Transcutaneous, Over-the-counter

Guangzhou Xinbo Electronic Co., Ltd.

The following data is part of a premarket notification filed by Guangzhou Xinbo Electronic Co., Ltd. with the FDA for Dr-ho's Back Pain Relief System Pro (models Bprs-i And Bprs-ii).

Pre-market Notification Details

Device IDK202671
510k NumberK202671
Device Name:DR-HO's Back Pain Relief System Pro (Models BPRS-I And BPRS-II)
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Guangzhou Xinbo Electronic Co., Ltd. No.23 Building, The Second Phase, Huachuang Animation Industry Park, Panyu Guangzhou,  CN 511450
ContactSammy Li
CorrespondentCassie Lee
Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou,  CN 510000
Product CodeNUH  
Subsequent Product CodeIRT
Subsequent Product CodeNGX
Subsequent Product CodeNYN
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-14
Decision Date2021-11-12

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