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 stimulator, nerve, transcutaneous, for pain relief
510(k) Number K202159
Device Name actiTENS
Applicant
Sublimed
137 Rue De Mayoussard
Moirans,  FR 38430
Applicant Contact Corinne Bulteau
Correspondent
Medical Device Academy, Inc.
345 Lincoln Hill Road
Shrewsbury,  VT  05738
Correspondent Contact Robert Packard
Regulation Number882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
IPF   NGX   NYN  
Date Received08/03/2020
Decision Date 12/22/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-