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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 K954568
Device Name THE REIFF QUANTUM WHEELCHAIR, OR QUANTUM WHEELCHAIRS
Applicant
Reif Wheelchairs and Accessories, Inc.
0510 N. 1000 E.
Lagrange,  IN  46761
Applicant Contact RICHARD E REIFF
Correspondent
Reif Wheelchairs and Accessories, Inc.
0510 N. 1000 E.
Lagrange,  IN  46761
Correspondent Contact RICHARD E REIFF
Regulation Number890.3850
Classification Product Code
IOR  
Date Received10/02/1995
Decision Date 10/31/1995
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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