Electrical Stimulator - Model R-C1 TENS And EMS Stimulator, Model R-E1 EMS Stimulator, Model R-T1 TENS Stimulator

Stimulator, Nerve, Transcutaneous, Over-the-counter

Shenzhen Roundwhale Technology Co., Ltd.

The following data is part of a premarket notification filed by Shenzhen Roundwhale Technology Co., Ltd. with the FDA for Electrical Stimulator - Model R-c1 Tens And Ems Stimulator, Model R-e1 Ems Stimulator, Model R-t1 Tens Stimulator.

Pre-market Notification Details

Device IDK180956
510k NumberK180956
Device Name:Electrical Stimulator - Model R-C1 TENS And EMS Stimulator, Model R-E1 EMS Stimulator, Model R-T1 TENS Stimulator
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Shenzhen Roundwhale Technology Co., Ltd. No. 615, Building C Of Sanlian Industrial Zone, Shiyan Baoan District Shenzhen,  CN 518108
ContactKevin Zhang
CorrespondentKevin Zhang
Shenzhen Roundwhale Technology Co., Ltd. No. 615, Building C Of Sanlian Industrial Zone, Shiyan Baoan District Shenzhen,  CN 518108
Product CodeNUH  
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-04-12
Decision Date2018-06-07
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00840001700086 K180956 000
10840001700021 K180956 000
10840001700038 K180956 000
00840001700048 K180956 000
00840001700055 K180956 000
00840001700062 K180956 000
00840001700079 K180956 000
18400017010013 K180956 000
00857771003996 K180956 000
10840001700014 K180956 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.