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 transcutaneous electrical spine stimulator to improve skeletal muscle strength and sensation
De Novo Number DEN240014
Device Name ARC-EX System
Requester
onward medical inc.
50 milk street
boston,  MA  02109
Contact nathalie gilat
Regulation Number890.5851
Classification Product Code
SDO  
Date Received03/28/2024
Decision Date 12/19/2024
Decision granted (DENG)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Neurology
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
-
-