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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wheelchair, standup
510(k) Number K122562
Device Name E-TENG MODEL EOR 1
Original Applicant
16f-2 (16a), no. 462, sec. 2
chongde rd, beitun dist.
taichung,  TW 406
Original Contact junnata chang
Regulation Number890.3900
Classification Product Code
Date Received08/22/2012
Decision Date 08/09/2013
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