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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 K071006
Device Name HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1
Applicant
Heartway Medical Products Co., Ltd.
#58, Fu-Chiun St.
Hsin-Chu City,  TW 408
Applicant Contact Ke-Min Jen
Correspondent
Heartway Medical Products Co., Ltd.
#58, Fu-Chiun St.
Hsin-Chu City,  TW 408
Correspondent Contact Ke-Min Jen
Regulation Number890.3860
Classification Product Code
ITI  
Date Received04/09/2007
Decision Date 05/21/2007
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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