Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Vehicle, Motorized 3-Wheeled
510(k) Number K162952
Device Name C.T.M. Mobility Scooter
Applicant
Chien TI Enterprise Co., Ltd.
# 13, Lane 227, Fu Ying Rd.
New Taipei City, Hsin Chuang District,  TW 24258
Applicant Contact VIVIAN LO
Correspondent
Chien TI Enterprise Co., Ltd.
# 13, Lane 227, Fu Ying Rd.
New Taipei City, Hsin Chuang District,  TW 24258
Correspondent Contact VIVIAN LO
Regulation Number890.3800
Classification Product Code
INI  
Date Received10/24/2016
Decision Date 05/03/2017
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
-
-