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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 K042748
Device Name GENEMAX POWER WHEELCHAIR, PW3
Applicant
Genemax Medical Products Industry Corp.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Applicant Contact Ke-Min Jen
Correspondent
Genemax Medical Products Industry Corp.
58 Fu-Chiun St.
Hsin Chu City,  TW 300
Correspondent Contact Ke-Min Jen
Regulation Number890.3860
Classification Product Code
ITI  
Date Received10/04/2004
Decision Date 11/12/2004
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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