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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 K102358
Device Name ZIP'R3/ ZIP'R3 XTRA SCOOTER
Applicant
Global Fabtech Wheelchair (Shanghai) Co., Ltd.
16f-2(16a), # 462, Sec. 2, Chongde Rd., Beitun Dist.
Taichung,  TW 406
Applicant Contact JUNNATA CHANG
Correspondent
Global Fabtech Wheelchair (Shanghai) Co., Ltd.
16f-2(16a), # 462, Sec. 2, Chongde Rd., Beitun Dist.
Taichung,  TW 406
Correspondent Contact JUNNATA CHANG
Regulation Number890.3800
Classification Product Code
INI  
Date Received08/19/2010
Decision Date 10/04/2010
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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