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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 Pkwy. N.
Suite 100
Minneapolis,  MN  55447 -4467
Applicant Contact E.P. (BERT) HARMAN
Correspondent
Otto Back Healthcare, LP
2 Carlson Pkwy. 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
Predetermined Change
Control Plan Authorized		 No
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