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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 K913272
Device Name EMS/400
Applicant
Altoona Medical Supply
705 2nd Ave., SW
Altoona,  IA  50009
Applicant Contact DONALD A MACKENZIE
Correspondent
Altoona Medical Supply
705 2nd Ave., SW
Altoona,  IA  50009
Correspondent Contact DONALD A MACKENZIE
Regulation Number890.5850
Classification Product Code
IPF  
Date Received07/23/1991
Decision Date 08/22/1991
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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