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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 K171071
Device Name StimSox(TM) System
Applicant
Stimmed, LLC
388 Evans St.
Williamsville,  NY  14221
Applicant Contact Peter G. Demakos
Correspondent
Wright Regulatory Consulting, Inc.
3900 Galt Ocean Dr.
Apt. 2501
Fort Lauderdale,  FL  33308
Correspondent Contact Marlene Wright Barton
Regulation Number890.5850
Classification Product Code
IPF  
Date Received04/10/2017
Decision Date 08/09/2017
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
Predetermined Change
Control Plan Authorized		 No
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