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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 K172381
Device Name Digitimer DS7AP Constant Current Stimulator
Applicant
Digitimer , Ltd.
37 Hydeway
Welwyn Garden City,  GB
Applicant Contact John Smale
Correspondent
Digitimer , Ltd.
37 Hydeway
Welwyn Garden City,  GB
Correspondent Contact John Smale
Regulation Number890.5850
Classification Product Code
IPF  
Date Received08/07/2017
Decision Date 03/06/2018
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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