Electrical Neuromuscular Stimulator (Cure Trio MC-130 IOS, Cure Trio MC-310 Android)

Stimulator, Nerve, Transcutaneous, Over-the-counter

Oriental Inspiration Limited

The following data is part of a premarket notification filed by Oriental Inspiration Limited with the FDA for Electrical Neuromuscular Stimulator (cure Trio Mc-130 Ios, Cure Trio Mc-310 Android).

Pre-market Notification Details

Device IDK212285
510k NumberK212285
Device Name:Electrical Neuromuscular Stimulator (Cure Trio MC-130 IOS, Cure Trio MC-310 Android)
ClassificationStimulator, Nerve, Transcutaneous, Over-the-counter
Applicant Oriental Inspiration Limited Unit D (01), 14/F.,Block 1,Tai Ping Industrial Centre, No. 57 Ting Kok Road, Tai Po, New Territories Hong Kong,  CN
ContactFrancis Ko
CorrespondentFrancis Ko
Oriental Inspiration Limited Unit D (01), 14/F.,Block 1,Tai Ping Industrial Centre, No. 57 Ting Kok Road, Tai Po, New Territories Hong Kong,  CN
Product CodeNUH  
Subsequent Product CodeNGX
Subsequent Product CodeNYN
CFR Regulation Number882.5890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-07-21
Decision Date2021-12-22

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