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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, For Pain Relief
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,# 57
Ting Kok Rd., 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,# 57
Ting Kok Rd., Tai Po,New Territories
Hong Kong,  CN
Correspondent Contact Francis Ko
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
GZI   IPF   NGX   NUH   NYN  
Date Received09/25/2023
Decision Date 04/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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