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Found 34 results
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?
Product Code :
LIH
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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K Number
K202725Device Name
ETD4000
Manufacturer
TheraSigma, LLC
Date Cleared
2021-03-26
(190 days)
Product Code
LIH
Regulation Number
882.5890Why did this record match?
Product Code :
LIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Interferential Current Stimulation: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.
Device Description
Not Found
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K Number
K183692Device Name
Avid IF2
Manufacturer
Vision Quest Industries Inc./ dba VQ OrthoCare
Date Cleared
2019-06-12
(163 days)
Product Code
LIH
Regulation Number
882.5890Why did this record match?
Product Code :
LIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Avid IF2 Interferential Stimulator, Model AV-IF19A is indicated for use in the following applications:
- -Symptomatic relief of post-surgical and/or post traumatic acute pain
- -Symptomatic relief of chronic intractable pain
-Relaxation of muscle spasms
-Maintaining and increasing range of motion
-Increases local blood circulation
Device Description
The Avid IF2, Model AV-IF19A is an Interferential Stimulator that produces a low electrical current that is transmitted via lead wires to electrodes placed on the skin in the area predetermined by a clinician. Operating parameters can be adjusted throughout their range by a trained clinician but the end-user is limited to protocol selection and amplitude. The user interface consists of an LCD display and a keypad.
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K Number
K122944Device Name
GEMORE TRUE SINE INTERFERENTIAL STIMULATOR
Manufacturer
GEMORE TECHNOLOGY CO., LTD.
Date Cleared
2012-12-21
(88 days)
Product Code
LIH
Regulation Number
882.5890Why did this record match?
Product Code :
LIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
Device Description
The Gemore IF series True sine interferential stimulator / Model: GM3A00IF/GM3A10IF/ GM3A20IF/GM3A50IF are the device which generates the small true-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin.
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K Number
K121662Device Name
VECTTOR VT-200
Manufacturer
ALAN NEUROMEDICAL TECHNOLOGIES LLC
Date Cleared
2012-11-21
(169 days)
Product Code
LIH
Regulation Number
882.5890Why did this record match?
Product Code :
LIH
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
The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on acupressure points of a patient's feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain. Once these electrodes are placed, the machine determines the appropriate stimulation intensity by automatically measuring body temperatures through the use of two specially designed Thermistors placed on the fingers during a testing sequence. The VT-200 delivers four channels of current from dual output jacks through Treatment Leads and Electrodes which are positioned on the patient's body according to treatment protocols.
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K Number
K110509Device Name
EVERYWAY INTERFERNTIAL STIMULATOR, MODEL IF-908
Manufacturer
EVERYWAY MEDICAL INSTRUMENTS CO., LTD.
Date Cleared
2011-06-20
(118 days)
Product Code
LIH
Regulation Number
882.5890Why did this record match?
Product Code :
LIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain. It is intended for use on the order of a physician only.
Device Description
The Everyway IF-908 Interferential stimulator is the device which generates the small ture-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved
The Everyway IF-809 interferential stimulator consists mainly of two parts: the stimulus generator, and electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief
The stimulation current is generated in such a way that the frequency in channel 1 is fixed, but frequency in channel 2 is adjustable. Also the output amplitude is also adjustable. Those adjustable parameters could provide user some stimulation output change depending upon the condition of patients according to the prescription of physician. In general IF-908 is the prescribtion device, which needs the physician instruction for stimulation treatment.
IF-908 provides two different alternative power supply system. <1> 9V internal battery, <2> 9V rechargeable battery pack charged by adaptor. The operator may recharge 9V battery pack for long term use via the power rechargeable battery system of IF-908. The battery pack can not be charged during operation via using 9V battery pack power.
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K Number
K100246Device Name
MAX-IF1000
Manufacturer
BIO PROTECH, INC.
Date Cleared
2010-11-24
(301 days)
Product Code
LIH
Regulation Number
882.5890Why did this record match?
Product Code :
LIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MAX-IF1000 interferential stimulator is used for symptomatic relief and management of chronic pain and/or an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.
Device Description
MAX-IF1000 Interferential Stimulator
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K Number
K092780Device Name
INF 4160 PLUS, MODEL D-FJ31F
Manufacturer
FUJI DYNAMICS LIMITED
Date Cleared
2010-01-07
(119 days)
Product Code
LIH
Regulation Number
882.5890Why did this record match?
Product Code :
LIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The INF 4160 PLUS is used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
Device Description
INF 4160 PLUS is an Interferential Current Therapy Device. It generates a set of symmetric sinusoidal electrical signals which are delivered to the user or patient through lead cables to the electrode pads placed on the skin. The electric signals stimulate the nerves underneath. The symptomatic relief from chronic intractable pain can be obtained from this electrical stimulation.
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K Number
K092763Device Name
IF TRUE SINE INTERFERENTIAL STIMULATOR, WL-2206D
Manufacturer
WELL-LIFE HEALTHCARE LIMITED
Date Cleared
2009-10-08
(29 days)
Product Code
LIH
Regulation Number
882.5890Why did this record match?
Product Code :
LIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
Device Description
The WL-2206D are the device which generates the small true-sine pulses of electrical current. The qenerated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin.
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K Number
K090023Device Name
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR, MODEL: WL-2206B AND WL-2106E
Manufacturer
WELL-LIFE HEALTHCARE LIMITED
Date Cleared
2009-01-30
(25 days)
Product Code
LIH
Regulation Number
882.5890Why did this record match?
Product Code :
LIH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain.
Device Description
The WL-2206B and WL-2106E are the device which generates the small true-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin.
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