510(k) K231575

Vecttor VT-300 by Artaflex, Inc. — Product Code LIH

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