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 Electromagnetic Stimulator, Pain Relief
510(k) Number K210021
Device Name Axon Therapy
Applicant
Neuralace Medical, Inc.
3770 Tansy St. #101
San Diego,  CA  92121
Applicant Contact Joe Milkovits
Correspondent
Acknowledge Regulatory Strategies, LLC
2251 San Diego Ave., Suite B-257
San Diego,  CA  92121
Correspondent Contact Allison C. Komiyama
Regulation Number882.5890
Classification Product Code
QPL  
Subsequent Product Code
IPF  
Date Received01/04/2021
Decision Date 06/11/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-