Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
510(k) Number |
K132563 |
Device Name |
PINOOK STIMULATOR |
Applicant |
PINOOK USA |
5703 OBERLIN DRIVE STE 306 |
SAN DIEGO,
CA
92121
|
|
Applicant Contact |
TEJAS SHAH |
Correspondent |
PINOOK USA |
5703 OBERLIN DRIVE STE 306 |
SAN DIEGO,
CA
92121
|
|
Correspondent Contact |
TEJAS SHAH |
Regulation Number | 882.5890
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/15/2013 |
Decision Date | 04/24/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|