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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Non-Implantable, For Incontinence
510(k) Number K213133
Device Name Keffort (MC-100, MC-100A)
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 Number876.5320
Classification Product Code
KPI  
Date Received09/27/2021
Decision Date 04/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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