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 K242719
Device Name ELEXIR 2.0 (ALLIVE3)
Applicant
Nu Eyne Co., Ltd.
#608, 28, Digital-Ro 30-Gil, Guro-Gu
Seoul,  KR 08389
Applicant Contact Dahee Kim
Correspondent
Nu Eyne Co., Ltd.
#608, 28, Digital-Ro 30-Gil, Guro-Gu
Seoul,  KR 08389
Correspondent Contact Dahee Kim
Regulation Number882.5891
Classification Product Code
PCC  
Date Received09/10/2024
Decision Date 11/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-