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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 K950656
Device Name PED ALERT
Applicant
Orbitec Technologies Corp.
402 Gammon Pl.
Suite 200
Madison,  WI  53719
Applicant Contact THOMAS M CRABB
Correspondent
Orbitec Technologies Corp.
402 Gammon Pl.
Suite 200
Madison,  WI  53719
Correspondent Contact THOMAS M CRABB
Regulation Number890.5575
Classification Product Code
IRN  
Date Received02/13/1995
Decision Date 10/25/1995
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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