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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
Applicant
E-TENG TECHNOLOGY, INC.
16F-2 (16A), NO. 462, SEC. 2
CHONGDE RD, BEITUN DIST.
TAICHUNG,  TW 406
Applicant Contact JUNNATA CHANG
Correspondent
E-TENG TECHNOLOGY, INC.
16F-2 (16A), NO. 462, SEC. 2
CHONGDE RD, BEITUN DIST.
TAICHUNG,  TW 406
Correspondent Contact JUNNATA CHANG
Regulation Number890.3900
Classification Product Code
IPL  
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
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