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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Elevator, Wheelchair, Portable
510(k) Number K901381
Device Name SUPERARM 2000 LIFT
Applicant
Handicaps, Inc.
4335 S. Santa Fe Dr.
Englewood,  CO  80110
Applicant Contact GERALDINE O'DELL
Correspondent
Handicaps, Inc.
4335 S. Santa Fe Dr.
Englewood,  CO  80110
Correspondent Contact GERALDINE O'DELL
Regulation Number890.3930
Classification Product Code
ING  
Date Received03/22/1990
Decision Date 04/16/1990
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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