Device Classification Name |
stimulator, transcutaneous electrical, aesthetic purposes
|
510(k) Number |
K131251 |
Device Name |
TRINITY ELE |
Applicant |
Carol Cole Company |
1325 Sycamore Ave Ste A |
Vista,
CA
92081
|
|
Applicant Contact |
Rand Daoud |
Correspondent |
Carol Cole Company |
1325 Sycamore Ave Ste A |
Vista,
CA
92081
|
|
Correspondent Contact |
Rand Daoud |
Regulation Number | 882.5890
|
Classification Product Code |
|
Date Received | 05/01/2013 |
Decision Date | 10/01/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|