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

Device Classification Under Section 513(f)(2)(De Novo)
  • 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 powered exoskeleton
De Novo Number DEN130034
510(K) Number K131798
Device Name REWALK
Requester
ARGO MEDICAL TECHNOLOGIES, INC.
33 locke dr.
suite 240
marlborough,  MA  01752
Contact john v hamilton
Regulation Number890.3480
Classification Product Code
PHL  
Date Received06/17/2013
Decision Date 06/26/2014
Decision granted (DENG)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct
-
-