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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, For Muscle Conditioning
510(k) Number K172876
Device Name PowerDot PD-01M
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
NGX  
Date Received09/21/2017
Decision Date 12/04/2017
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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