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, Over-The-Counter
510(k) Number K183110
Device Name LIVIA
Applicant
Lifecare , Ltd.
Zipori St.2
Tiberias,  IL 1424602
Applicant Contact Amnon Nahum Sharon
Correspondent
Cohen, Tauber, Spievack & Wagner
420 Lexington Ave. - Suite 2400
New York,  NY  10170
Correspondent Contact Irving L. Wiesen
Regulation Number882.5890
Classification Product Code
NUH  
Date Received11/08/2018
Decision Date 05/04/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT03064945
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-