K231575 is an FDA 510(k) clearance for the Vecttor VT-300. This device is classified as a Interferential Current Therapy (Class II - Special Controls, product code LIH).
Submitted by Artaflex, Inc. (Markham, CA). The FDA issued a Cleared decision on February 8, 2024, 253 days after receiving the submission on May 31, 2023.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K231575 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 31, 2023 |
| Decision Date | February 08, 2024 |
| Days to Decision | 253 days |
| Submission Type | Abbreviated |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | LIH — Interferential Current Therapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |