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510(k) Data Aggregation
K Number
K231575Device Name
Vecttor VT-300
Manufacturer
Artaflex Inc.
Date Cleared
2024-02-08
(253 days)
Product Code
LIH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Artaflex Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Electrical stimulation delivered by the device is intended for the symptomatic relief of chronic intractable pain and or management of post-traumatic or post-surgical pain.
Device Description
VT-300 device is portable and battery operated. VT-300 Device is comprised of a PCBA and a lithium-ion battery enclosed in a polycarbonate housing. The device's dimensions are 2.1 inches wide, 3.3 inches long, and 0.75 inch in height.
Vecttor VT-300 provides Interferential Current Therapy. Eight electrodes attached to a pair of lead wires are intended to be positioned on the patient's body to deliver four channels of current from VT-300 dual output jacks. Temperature sensors continually monitor finger surface temperatures with the intention of identifying and then applying an Interferential Current Therapy level that results in specified temperature increases.
The user controls the VT-300 device using Vecttor Mobile App which is a mobile application downloadable on Bluetooth enabled mobile devices using Android or iOS operating systems from the Google Play or Apple App store. Vecttor Mobile App provides the necessary user interface to establish connection to the VT-300 device via Bluetooth, and operate VT-300 device to provide interferential current therapy.
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