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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 K150078
FOIA Releasable 510(k) K150078
Device Name PowerDot(R) PD-01 Muscle Stimulator (with PowerDot(R) Mobile Application)
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 Received01/15/2015
Decision Date 09/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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