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 K150086
Device Name Titan
Applicant
Tzora Active Systems , Ltd.
Kibbutz Tzora,  IL 9980300
Applicant Contact Adi Shemer
Correspondent
A. Stein-Regulatory Affairs Consulting, Ltd.
20 Hata'As St.(P.O. Box 124)
Kfar Saba,  IL 4442520
Correspondent Contact Moshe Rosenberg
Regulation Number890.3800
Classification Product Code
INI  
Date Received01/15/2015
Decision Date 08/05/2015
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
-
-