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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 K043332
Device Name WHEELCHAIR, MODEL 8500-II
Applicant
Cycling and Health Tech. Industry R&D Center
111-X60, Lane 68
Fu-Hsing N. Rd.
Taichung,  TW 407
Applicant Contact ZEN-JYE CHEN
Correspondent
Cycling and Health Tech. Industry R&D Center
111-X60, Lane 68
Fu-Hsing N. Rd.
Taichung,  TW 407
Correspondent Contact ZEN-JYE CHEN
Regulation Number890.3850
Classification Product Code
IOR  
Date Received12/02/2004
Decision Date 12/13/2004
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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