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 Avenue - Suite 2400 |
New York,
NY
10170
|
|
Correspondent Contact |
Irving L. Wiesen |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 11/08/2018 |
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
|
|
|