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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K022924
Device Name SHERPA MOBILITY SYSTEM (MANUAL WHEELCHAIR)
Applicant
OTTO BACK HEALTHCARE, LP
2 CARLSON PARKWAY N.
SUITE 100
MINNEAPOLIS,  MN  55447 -4467
Applicant Contact E.P. (BERT) HARMAN
Correspondent
OTTO BACK HEALTHCARE, LP
2 CARLSON PARKWAY N.
SUITE 100
MINNEAPOLIS,  MN  55447 -4467
Correspondent Contact E.P. (BERT) HARMAN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/04/2002
Decision Date 10/17/2002
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
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