510(k) K231575
K231575 is an FDA 510(k) premarket notification submitted by Artaflex, Inc. for the device "Vecttor VT-300". The FDA issued a decision of Substantially Equivalent on February 8, 2024. The device falls under product code LIH (Interferential Current Therapy), a Class II device regulated under 21 CFR 882.5890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 8, 2024
- Date Received
- May 31, 2023
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Interferential Current Therapy
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type