| Device Classification Name |
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
|
| 510(k) Number |
K150077 |
| Device Name |
SonicLift |
| Applicant |
| PRETIKA CORPORATION |
| 12215 Holly Street |
|
Riverside,
CA
92509
|
|
| Applicant Contact |
Thomas Nichols |
| Correspondent |
| PRETIKA CORPORATION |
| 12215 Holly Street |
|
Riverside,
CA
92509
|
|
| Correspondent Contact |
Thomas Nichols |
| Regulation Number | 882.5890 |
| Classification Product Code |
|
| Subsequent Product Code |
|
| Date Received | 01/14/2015 |
| Decision Date | 11/25/2015 |
| 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
|
|
|