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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 K072104
Device Name HEARTWAY POWER MOBILITY SCOOTER, PF6
Applicant
Heartway Medical Products Co., Ltd.
Rd. 25, # 6
Taichung Industrial Park
Taichung,  TW 408
Applicant Contact HSIANG-PIN HUANG
Correspondent
Heartway Medical Products Co., Ltd.
Rd. 25, # 6
Taichung Industrial Park
Taichung,  TW 408
Correspondent Contact HSIANG-PIN HUANG
Regulation Number890.3800
Classification Product Code
INI  
Date Received07/31/2007
Decision Date 08/17/2007
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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