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510(k) Data Aggregation
K Number
K130816Device Name
INTERX STERILE SELF-ADHESIVE DUAL ELECTRODE (ISSDE)
Manufacturer
NEURO RESOURCE GROUP, INC.
Date Cleared
2013-06-21
(88 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
NEURO RESOURCE GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ISSDE is indicated for use with InterX Transcutaneous Electrical Nerve Stimulator. The ISSDE provides the conductive interface between the InterX stimulation device and the patient's skin. The ISSDE is not made with natural rubber latex, is reusable (single patient only), and is provided packaged and labeled as a sterile device, for single patient use. As a sterile device, the ISSDE can be applied to patients in a sterile post-operative healthcare setting. NRG only guarantees sterility for the first application, however, ISSDE can be repositioned and reapplied (single patient only) as a non-sterile device for subsequent applications. Refer to the labeling for reuse instructions.
Device Description
The Proposed ISSDE is a flexible, sterile laminate composed of a top cover, a reinforcement film, dual conductive members with printed silver, biocompatible conductive hydrogel, a release liner which protects the hydrogel before use and during storage and a 2-conductor cable secured between the reinforcement film and the conductive members. The electrodes do not contain active electronics, software or firmware. The cable connects the dual-electrode to the Inter X electrical stimulation device. A single finished dual-electrode is placed into a protective pouch which is then sealed, gamma sterilized and boxed for shipment. The Proposed ISSDE is designed for single-patient/multiple application use.
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K Number
K070217Device Name
INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE
Manufacturer
NEURO RESOURCE GROUP, INC.
Date Cleared
2008-04-04
(437 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
NEURO RESOURCE GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for cosmetic use.
Device Description
The InterX 1000/Derma 200 Stimulator for Cosmetic Use is a hand-held, battery operated device consisting of a main operating unit (InterX 1000) and an external electrode (Derma 200).
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K Number
K053626Device Name
INTERX500 FLEXIBLE ARRAY ELECTRODE
Manufacturer
NEURO RESOURCE GROUP, INC.
Date Cleared
2006-03-29
(91 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
NEURO RESOURCE GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InterX500 Flexible Array Electrode is intended to be used with authorized InterX TENS and/or Powered Muscle Stimulator devices for the purpose of applying electrical stimulation.
Device Description
The InterX500 Flexible Array Electrode consists of stainless steel electrodes assembled in a biomedical grade silicone rubber. The electrodes are connected to each other by wiring through a connector cable. There is no power to the InterX500 Flexible Array Electrode unless it is connected to interactive electrostimulation device provided by Neuro Resource Group, Inc. The InterX500 Flexible Array Electrode is placed directly onto unbroken skin and does not use any conductive gels. The connector is medically recognized and cannot be plugged into an AC socket. The InterX500 Flexible Array Electrode is an optional external electrode accessory for an interactive electrostimulation device provided by Neuro Resource Group. The electrode serves as an extension to the device to allow the user to apply treatment in larger and less accessible areas by the electrodes on the interactive electrostimulation device. The InterX500 Flexible Array Electrode is intended to be used with a Neuro Resource Group, Inc. provided electrostimulation device and does not contain any active electrical components. The cable is a two conductor cable using two 24 AWG single wires tinned with copper. The cable is UL and CSA approved.
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K Number
K042912Device Name
INTERX5000
Manufacturer
NEURO RESOURCE GROUP, INC.
Date Cleared
2005-05-17
(208 days)
Product Code
GZJ, IPF
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
NEURO RESOURCE GROUP, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InterX5000 is indicated for symptomatic relief and management of chronic, intractable pain, and adjunctive treatment in the management of post-surgical and post-traumatic pain.
The InterX5000 is indicated for:
- symptomatic relief and management of chronic, intractable pain
- adjunctive treatment in the management of post-surgical and post-traumatic pain
- relaxing muscle spasms
- increasing local blood circulation
- immediate post surgical stimulation of calf muscles to prevent venous thrombosis
- muscle reeducation
- maintaining or increasing range of motion
- preventing or retarding disuse atrophy
Device Description
InterX means "Interactive". InterX technology is designed to work by introducing very brief pulses of electricity into the tissue and immediately monitoring impedance changes as the tissue responds. Stimulation and sensing take place via a concentric electrode system that is moved over the skin surface, and a digital display enables the operator to follow the course of the treatments and adjust the output.
The InterX 5000 consists of a small handheld device in a plastic case. It is powered by one nine-volt alkaline battery. On the upper face of the machine there are two LED's, an LCD display and 5 control buttons. The underside of the machine two metal surfaces that form the poles of a treatment electrodes are placed directly on the unbroken skin and do not use any conductive material or gel.
On the side of the machine is one socket for a standard 3.5mm stereo jack socket that connects to the main electrodes of the machine to an optional external electrode accessory. The device's electrodes are disabled when the optional external electrode accessory is attached. The optional external electrode accessories only serve as an extension and allow the user to apply treatment in a areas which may not be accessible by the main unit electrodes. user to apply ucannell in a accessories intended for use with the InterX 5000 have any active electrical components.
The waveform is a high amplitude, short-duration bi-polar pulse (circuitry in the device integrates time and dosage delivered). A digital display monitors the biofeedback process in mtegrates thire and dosage convolling the operator to track changes in the tissues being treated and make appropriate adjustments to the output characteristics if necessary. This interaction and human adjustment continues throughout the length of the InterX treatment. The result is that the body experiences a conditioned training process that enhances the body's ability to effectively reduce and manage the level of pain.
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