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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 K080242
Device Name HEARTWAY POWER MOBILITY SCOOTER, PF7
Applicant
Heartway Medical Products Co., Ltd.
#58, Fu-Chiun St.
Hsin-Chu City,  TW 408
Applicant Contact JEN KE-MIN
Correspondent
Heartway Medical Products Co., Ltd.
#58, Fu-Chiun St.
Hsin-Chu City,  TW 408
Correspondent Contact JEN KE-MIN
Regulation Number890.3800
Classification Product Code
INI  
Date Received01/31/2008
Decision Date 02/27/2008
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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