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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Warning, Overload, External Limb, Powered
510(k) Number K962591
Device Name FOOT WEIGHT ALARM
Applicant
CLEVELAND MEDICAL DEVICES, INC.
11000 CEDAR AVE., SUITE 130
CLEVELAND,  OH  44106
Applicant Contact ROBERT N SCHMIDT
Correspondent
CLEVELAND MEDICAL DEVICES, INC.
11000 CEDAR AVE., SUITE 130
CLEVELAND,  OH  44106
Correspondent Contact ROBERT N SCHMIDT
Regulation Number890.5575
Classification Product Code
IRN  
Subsequent Product Code
IKE  
Date Received07/02/1996
Decision Date 12/04/1996
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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