Device Classification Name |
Stimulator, Nerve, Transcutaneous, For Pain Relief
|
510(k) Number |
K131513 |
Device Name |
SCENAR (SCELAP, ENISAR, IPENS) CUTANEOUS ELECTRODE FAMILY |
Applicant |
RITM OKB ZAO |
99, PETROVSKAYA |
TAGANROG,
RU
347900
|
|
Applicant Contact |
LARISA SHPUNGINA |
Correspondent |
RITM OKB ZAO |
99, PETROVSKAYA |
TAGANROG,
RU
347900
|
|
Correspondent Contact |
LARISA SHPUNGINA |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/28/2013 |
Decision Date | 07/11/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|