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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
NO. 17 RD.
TAICHUNG INDUSTRY PARK
TAICHUNG,  TW 407
Applicant Contact CHANG WAN LAN
Correspondent
CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER
NO. 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
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