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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 K043326
Device Name BEWELL, MODEL SC 20
Applicant
Cycling and Health Tech. Industry R&D Center
# 17 Rd.
Taichung Industry Park
Taichung,  TW 407
Applicant Contact CHANG WAN LAN
Correspondent
Cycling and Health Tech. Industry R&D Center
# 17 Rd.
Taichung Industry Park
Taichung,  TW 407
Correspondent Contact CHANG WAN LAN
Regulation Number890.3800
Classification Product Code
INI  
Date Received12/02/2004
Decision Date 01/26/2005
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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