| Device Classification Name |
Stimulator, Muscle, Powered
|
| 510(k) Number |
K202490 |
| Device Name |
Avid CT2 |
| Applicant |
| Vision Quest Industries Inc./Dba VQ Orthocare |
| 1390 Decision St., Suite A |
|
Vista,
CA
92081
|
|
| Applicant Contact |
Mohamed Ouerghi |
| Correspondent |
| Vision Quest Industries Inc./Dba VQ Orthocare |
| 1390 Decision St., Suite A |
|
Vista,
CA
92081
|
|
| Correspondent Contact |
Mohamed Ouerghi |
| Regulation Number | 890.5850 |
| Classification Product Code |
|
| Subsequent Product Code |
|
| Date Received | 08/31/2020 |
| Decision Date | 11/16/2020 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Physical Medicine
|
| 510k Review Panel |
Neurology
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|