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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 K931517
Device Name SAFE-STEP
Original Applicant
13402 south prairie ave.
hawthorne,  CA  90250
Regulation Number890.5575
Classification Product Code
Date Received03/26/1993
Decision Date 03/10/1995
Decision substantially equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No