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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K935201
Device Name QUADTRAX
Applicant
Body Bike, Inc.
Star Route, Box 8,
Lyman Daniel Rd.
Trenton,  GA  30752
Applicant Contact ROBERT EDWARDS
Correspondent
Body Bike, Inc.
Star Route, Box 8,
Lyman Daniel Rd.
Trenton,  GA  30752
Correspondent Contact ROBERT EDWARDS
Regulation Number890.3860
Classification Product Code
ITI  
Date Received10/27/1993
Decision Date 05/06/1994
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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