| Device Classification Name |
Stimulator, Nerve, Transcutaneous, Over-The-Counter
|
| 510(k) Number |
K120500 |
| Device Name |
THE PAIN PILOT (A.K.A PAIN PILOT) |
| Applicant |
| Hollywog, LLC |
| 2830 Amnicola Hwy. |
|
Chattanooga,
TN
37406
|
|
| Applicant Contact |
MICHAEL W TREAS |
| Correspondent |
| Hollywog, LLC |
| 2830 Amnicola Hwy. |
|
Chattanooga,
TN
37406
|
|
| Correspondent Contact |
MICHAEL W TREAS |
| Regulation Number | 882.5890 |
| Classification Product Code |
|
| Date Received | 02/21/2012 |
| Decision Date | 08/20/2012 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Neurology
|
| 510k Review Panel |
Neurology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|