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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 K181759
Device Name PowerDot PD-01MT
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 Received07/02/2018
Decision Date 11/09/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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