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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K210938
Device Name PowerDot PD-01MT2 Muscle Stimulator
Applicant
Smartmissimo Technologies Pte, Ltd.
#28-01, Sgx Centre Ii, 4 Shenton Way
Singapore,  SG 068807
Applicant Contact Alexey Pisarev
Correspondent
Smartmissimo Technologies Pte, Ltd.
#28-01, Sgx Centre Ii, 4 Shenton Way
Singapore,  SG 068807
Correspondent Contact Alexey Pisarev
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   NGX   NUH  
Date Received03/29/2021
Decision Date 07/30/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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