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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 K792241
Device Name PELIMIT
Applicant
Colmed, Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Colmed, Ltd.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number890.5575
Classification Product Code
IRN  
Date Received11/07/1979
Decision Date 11/30/1979
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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