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 Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
510(k) Number K251821
Device Name ARC-EX System
Applicant
Onward Medical, Inc.
50 Milk St.
Boston,  MA  02109
Applicant Contact Nathalie Gilat
Correspondent
Onward Medical, Inc.
50 Milk St.
Boston,  MA  02109
Correspondent Contact Nathalie Gilat
Classification Product Code
SDO  
Date Received06/13/2025
Decision Date 11/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-