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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 K233046
Device Name Electrical Neuromuscular Stimulator, Cure Trio
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
GZI   GZJ   IPF   KPI   NGX  
NYN  
Date Received09/25/2023
Decision Date 04/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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