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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K071007
Device Name HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33
Applicant
HEARTWAY MEDICAL PRODUCTS CO., LTD.
NO.58, FU-CHIUN ST.
HSIN-CHU CITY,  TW 408
Applicant Contact Ke-Min Jen
Correspondent
HEARTWAY MEDICAL PRODUCTS CO., LTD.
NO.58, FU-CHIUN ST.
HSIN-CHU CITY,  TW 408
Correspondent Contact Ke-Min Jen
Regulation Number890.3800
Classification Product Code
INI  
Date Received04/09/2007
Decision Date 04/19/2007
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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