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, electrical, transcutaneous, for migraine
510(k) Number K212071
Device Name Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx
Applicant
CEFALY Technology
Rue Louis Plescia 34
Seraing,  BE 4102
Applicant Contact Rufus Kay Moberly
Correspondent
Elexes Medical Consulting, LLC
30 N Gould St Ste R
Sheridan,  WY  82801
Correspondent Contact Parul Chansoria
Regulation Number882.5891
Classification Product Code
PCC  
Date Received07/02/2021
Decision Date 12/13/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-