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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K062888
Device Name MIDDLE WHEEL DRIVE POWER CHAIR, CWD01
Applicant
Emg Technology Co., Ltd.
# 58, Fu-Chinu St.
Hsin-Chu City,  TW 300
Applicant Contact Ke-Min Jen
Correspondent
Emg Technology Co., Ltd.
# 58, Fu-Chinu St.
Hsin-Chu City,  TW 300
Correspondent Contact Ke-Min Jen
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/26/2006
Decision Date 10/24/2006
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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