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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 K880699
Device Name ENDOMED CV405
Applicant
Henley Intl.
10518 Kinghurst
Houston,  TX  77099
Applicant Contact ERNEST J HENLEY,PHD
Correspondent
Henley Intl.
10518 Kinghurst
Houston,  TX  77099
Correspondent Contact ERNEST J HENLEY,PHD
Regulation Number890.5850
Classification Product Code
IPF  
Date Received02/22/1988
Decision Date 05/02/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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