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 Interactive Rehabilitation Exercise Devices
510(k) Number K150462
Device Name Vera
Applicant
Reflexion Health, Inc.
223 Broadway, Suite 650
San Diego,  CA  92130
Applicant Contact Huan Tran
Correspondent
Reflexion Health, Inc.
223 Broadway, Suite 650
San Diego,  CA  92130
Correspondent Contact Huan Tran
Regulation Number890.5360
Classification Product Code
LXJ  
Date Received02/23/2015
Decision Date 10/30/2015
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
-
-