K202490 is an FDA 510(k) clearance for the Avid CT2. This device is classified as a Stimulator, Muscle, Powered (Class II - Special Controls, product code IPF).
Submitted by Vision Quest Industries Inc./Dba VQ Orthocare (Vista, US). The FDA issued a Cleared decision on November 16, 2020, 77 days after receiving the submission on August 31, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 890.5850.
| 510(k) Number | K202490 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 31, 2020 |
| Decision Date | November 16, 2020 |
| Days to Decision | 77 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | IPF — Stimulator, Muscle, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5850 |