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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stimulator, nerve, transcutaneous, over-the-counter
510(k) Number K212285
Device Name Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android)
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
Applicant Contact Francis Ko
Correspondent
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
Correspondent Contact Francis Ko
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
NGX   NYN  
Date Received07/21/2021
Decision Date 12/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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