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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 K133638
Device Name GEKO
Applicant
Firstkind Limited
231 Fairbanks St.
West Boylston,  MA  01583
Applicant Contact SHEILA HEMEON-HEYER
Correspondent
Firstkind Limited
231 Fairbanks St.
West Boylston,  MA  01583
Correspondent Contact SHEILA HEMEON-HEYER
Regulation Number890.5850
Classification Product Code
IPF  
Date Received11/27/2013
Decision Date 08/21/2014
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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