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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 K022493
Device Name EMS 400
Applicant
BODY CLOCK HEALTH CARE LTD
108 GEORGE LANE
SOUTH WOODFORD, LONDON,  GB E18 1AD
Applicant Contact JONATHAN BASH
Correspondent
BODY CLOCK HEALTH CARE LTD
108 GEORGE LANE
SOUTH WOODFORD, LONDON,  GB E18 1AD
Correspondent Contact JONATHAN BASH
Regulation Number890.5850
Classification Product Code
IPF  
Date Received07/29/2002
Decision Date 10/11/2002
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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