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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Standup
510(k) Number K946110
Device Name REGAIN STAND-UP WHEELCHAIR
Applicant
Regain, Inc.
5577 Vantage Pt.
Columbia,  MD  21044
Applicant Contact MICHAEL H GALUMBECK
Correspondent
Regain, Inc.
5577 Vantage Pt.
Columbia,  MD  21044
Correspondent Contact MICHAEL H GALUMBECK
Regulation Number890.3900
Classification Product Code
IPL  
Date Received12/14/1994
Decision Date 02/01/1995
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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