Vecttor VT-300

FDA 510(k) K231575 · Artaflex, Inc.

Substantially Equivalent

510(k) numberK231575

Submission

Device name
Vecttor VT-300
Applicant
Artaflex, Inc.
Markham, CA
Received
May 31, 2023
Decision date
February 8, 2024
Decision
Substantially Equivalent (SESE)
Type
Abbreviated 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LIH – Interferential Current Therapy
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

Other 510(k)s with product code LIH

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K122944Gemore True Sine Interferential StimulatorLIH · Special Gemore Technology Co, Ltd.12/21/2012SE
K121662Vecttor VT-200LIH · Abbreviated Alan Neuromedical Technologies, LLC11/21/2012SE
K110509Everyway Interferntial Stimulator, Model IF-908LIH · Traditional Everyway Medical Instruments Co.,Ltd06/20/2011SE
K100246MAX-IF1000LIH · Traditional Bio Protech, Inc.11/24/2010SE
K092780Inf 4160 Plus, Model D-FJ31FLIH · Traditional Fuji Dynamics Limited01/07/2010SE
K092763If True Sine Interferential Stimulator, WL-2206DLIH · Special Well-Life Healthcare Limited10/08/2009SE
K090023If Series True Sine Interferential Stimulator, Model: WL-2206B and WL-2106ELIH · Special Well-Life Healthcare Limited01/30/2009SE
K070890Everlife Interferential Current Therapy, Model IF-100507LIH · Traditional Everlife Medical Equipment Co., Ltd.06/29/2007SE

Questions and answers

When was Vecttor VT-300 cleared by the FDA?

Vecttor VT-300 (K231575) received a 510(k) decision of Substantially Equivalent on February 8, 2024, 253 days after the submission was received.

What is the product code of K231575?

The FDA product code is LIH – Interferential Current Therapy, a Class II (moderate risk) device regulated under 21 CFR 882.5890.