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The Ouell-FM is a transcutaneous electrical nerve stimulation (TENS) device indicated as an aid for reducing the symptoms of fibromyalgia in adults with high pain sensitivity. The Quell-FM may be used during sleep. The Quell-FM is labeled for use only with compatible NeuroMetrix electrodes.

Ouell-FM is a wearable, transcutaneous electrical nerve stimulator designed to stimulate sensory nerves in the upper-calf region. The device utilizes a microprocessor running embedded software and a custom high-voltage Application Specific Integrated Circuit (ASIC) to generate current regulated stimulating pulses with specific characteristics including pulse shape, amplitude, duration, pattern, and frequency. The device utilizes Bluetooth® low energy (BLE) to communicate with a mobile device that allows the user to start and stop therapy, control stimulation intensity, and modify certain operating characteristics. The device is powered by an embedded rechargeable lithium-ion polymer battery that is charged through a USB cable connected to an AC adapter. The primary components of the device include the Quell-FM device, Band, Electrodes, and Quell-FM mobile app. - A. Quell-FM Device The Quell-FM device delivers electrical stimulation to the user through a disposable electrode placed on the user's body. The Quell-FM is labeled for use only with compatible NeuroMetrix electrodes (previously cleared in K140586), to which it connects through insulated female medical snap connectors embedded within its housing; no lead-wires are used. - B. Band A flexible band secures the Quell-FM device and the electrode to the user's leg using a hook and loop material. - C. Electrodes The Quell-FM device is labeled for use only with compatible NeuroMetrix electrodes (i.e., electrodes cleared under K140586). This use specification, in part, ensures the safe use of the device during sleep because NeuroMetrix electrodes have a known surface area that allows the device to quantitively determine relative skin contact area. Stimulation will be automatically stopped if device detects a decrease in skin-contact area which may lead to unsafe current density to be delivered as would occur during unattended use such as sleeping. - D. Quell-FM Mobile App Quell-FM is used with a mobile app, running on an iOS or Android mobile device, to which it communicates via Bluetooth. Using the mobile app, the user can start and stop the therapy, control stimulation intensity, and modify certain operating characteristics.

Quell is intended for use as a transcutaneous electrical nerve stimulation device for temporary relief of pain associated with sore and aching muscles in the lower extremities due to strain from exercise or normal household and work activities. Quell is intended for use as a transcutaneous electrical nerve stimulation device for the symptomatic relief and management of chronic intractable pain. The device may be used during sleep. The device is labeled for use only with compatible NeuroMetrix electrodes.

Quell is a single output-mode transcutaneous electrical nerve stimulator for symptomatic relief and management of chronic intractable pain that is sold without a prescription. - The device utilizes a microprocessor running embedded software to control a high-voltage circuit that generates currentregulated stimulating pulses with specific technical characteristics including pulse shape, amplitude, duration, pattern, and frequency. The device is powered by an embedded rechargeable Lithium-Ion battery that is charged through a USB cable connected to an AC adapter. The device delivers electrical stimulation to the user through a disposable electrode placed on the user's body. The device is labeled for use only with compatible NeuroMetrix electrodes (e.g., K140586). to which it connects through insulated female medical snap connectors embedded within its housing; no lead-wires are used. The user interface consists of a push button and a linear 6 LED array consisting of 5 white LEDs and 1 amber LED. The LED array indicates stimulation status, battery charging, and error conditions. A Quell user may initiate therapy, increase stimulation intensity and decrease stimulation intensity through a wireless control mechanism that is collectively referred to as the "virtual button." The virtual button is available through the Quell mobile app and is intended for use in the same environments as the Quell device.

The ASCEND Electrode is intended for use as disposable, conductive, adhesive interface between the user's skin and a transcutaneous electrical nerve stimulator.

The ASCEND Electrode provides an electrically conductive interface between a transcutaneous electrical nerve stimulator and a user's skin. It is intended to be disposable and for single person use. It is provided non-sterile.

ASCEND is intended for use as a transcutaneous electrical nerve stimulation device for temporary relief of pain associated with sore and aching muscles in the lower extremities due to strain from exercise or normal household and work activities. ASCEND is intended for use as a transcutaneous electrical nerve stimulation device for the symptomatic relief and management of chronic intractable pain. The device may be used during sleep. The device is labeled for use only with compatible NeuroMetrix electrodes.

ASCEND is a single output-mode transcutaneous electrical nerve stimulator for symptomatic relief and management of chronic intractable pain that is available over the counter. The device utilizes a microprocessor running embedded software to control a high-voltage circuit that generates currentregulated stimulating pulses with specific technical characteristics including pulse shape, amplitude, duration, pattern, and frequency. The device is powered by an embedded rechargeable Lithium-Ion battery that is charged through a USB cable connected to an AC adapter. The device delivers electrical stimulation to the user through disposable electrodes placed on the user's body. The device is labeled for use only with compatible NeuroMetrix electrodes (e.g. SENSUS Electrode, K121816), to which it connects through insulated female medical snap connectors embedded within its housing; no lead-wires are used. Compatible NeuroMetrix electrodes are comprised of four individual hydrogel pads arranged in a linear array. The hydrogel pads are electrically connected in pairs such that the two outer hydrogel pads constitute one electrode and the two inner hydrogel pads constitute a second electrode. The user interface consists of a push button and a two-color LED. The push button initiates and controls stimulation intensity. The LED indicates stimulation status, battery charging, and error conditions.

The NeuroMetrix SENSUS is intended for use as a transcutaneous electric nerve stimulation device for the symptomatic relief and management of chronic intractable pain. The device may be used during sleep. The device is labeled for use only with the NeuroMetrix SENSUS Electrode.

The SENSUS device, is a transcutaneous electrical nerve stimulator with a single output mode. The device utilizes a microprocessor running embedded software to control a high-voltage circuit that generates stimulating pulses with specific technical characteristics including pulse shape, amplitude (current), duration, pattern, and frequency. The device is powered by a permanent rechargeable Lithium-Ion battery that is charged through a USB cable connected to an AC adapter. The device delivers electrical stimulation to the patient through disposable, single-patient use electrodes placed on the patient's body. The device is labeled for use only with the SENSUS Electrode (K121816), to which it connects through insulated female medical snap connectors embedded within its housing. The device has a push-button that initiates stimulation, and controls the intensity. The device has a single two color LED for indication of stimulation status, battery charging, and error conditions.

The NeuroMetrix SENSUS Electrode is intended for use as disposable, conductive, adhesive interface between the patient's skin and a transcutaneous electrical nerve stimulator.

The SENSUS Electrode provides an electrically conductive interface between a transcutaneous electrical nerve stimulator and a patient's skin. It is provided non-sterile, is designed and intended for single patient use only, and to be disposable. The SENSUS Electrode is comprised of four individual electrodes, each of size 36 by 46 mm. The overall dimensions are 50 by 280 mm. The individual electrodes are electrically connected in pairs such that the two outer electrodes constitute one pair and the two inner electrodes constitute a second pair. The SENSUS Electrode contains two conventional male snap connectors for electrical connection to a transcutaneous electrical nerve stimulator. The SENSUS Electrode has a multi-layer design. The first and outermost layer is a sheet of Mylar. The second layer contains conductive silver traces and silver electrode pads. Where the silver traces are not covered by hydrogel, they are covered by a dielectric mask. The third layer is the four individual electrodes which consist of a medical grade, self adhering, biocompatible hydrogel (KM-10G, Katecho, Inc., Des Moines, IA). When not in use, the hydrogel is covered by a Mylar release liner. Two male type snap connectors interface the SENSUS Electrode to the transcutaneous electrical nerve stimulator. The patient facing surface of the snap connectors are either under hydrogel or covered by a laminated dielectric polypropylene layer. Therefore in both cases the snap connectors do not directly contact the patient's skin.

The NeuroMetrix SENSUS device is intended for use as a transcutaneous electrical nerve stimulator for the symptomatic relief and management of chronic intractable pain.

SENSUS is a one-channel transcutaneous electrical nerve stimulator with a single output mode. The stimulator utilizes a microprocessor running embedded software to control a high-voltage circuit that generates stimulating pulses with specific technical characteristics including waveform shape, current intensity, waveform duration and frequency. The stimulator is powered by a permanent rechargeable Lithium-Ion battery that is recharged through a USB cable connected to an AC adapter. The stimulator delivers electrical stimulation to the patient through two disposable, single-patient use electrodes placed on the patient's body. The stimulator, as labeled, is for use with legally available electrodes. The electrodes should be self-adhering with an electrical connection made through a male medical snap connector and an electrode area ≥ 20 cm2. The stimulator connects to the electrodes through a patient cable consisting of two lead-wires that terminate in an insulated female medical snap connector. The stimulator has a push-button that initiates and halts stimulation. Taps to the stimulator enclosure, detected by an embedded accelerometer, control the stimulation intensity. The push button serves the dual purpose of powering up the device from a standby state and initiating and halting stimulation.

NeuroMetrix ASCEND is a peripheral nerve stimulator used for localization and verification of needle placement for perineural application of pharmacological agents.

ASCEND is a battery powered peripheral nerve stimulator. This device is intended for localization and verification of needle placement for perineural application of pharmacological agents. ASCEND consists of the following components: Stimulator, Battery, Bluetooth, Charging Station.

The NeuroMetrix Bioamplifier is intended for amplification and transmission of the electrical activity of peripheral nerves and muscles recorded through surface electrodes.

The NeuroMetrix Bioamplifier ("Bioamplifier") is a one channel wireless electromyography amplifier. This device is intended to differentially measure, amplify, digitize, and wirelessly transmit bioelectrical signals from peripheral nerves and muscles transduced by surface electrodes, which are provided separately. The Bioamplifier consists of the following components: Amplifier/Digitization Unit, Battery, RF Trigger, and Bluetooth. The Bioamplifier is typically used with a host device that controls the operation of the Bioamplifier and may provide other functionality such as a user interface, electrical or other stimuli, data analysis, data storage, and document generation.

The NeuroMetrix UNIVERSAL Electrodes are intended for use with electrodiagnostic equipment for the recording of electrophysiological activity from peripheral nerves and muscles, and for peripheral nerve electrical stimulation UNIVERSAL Electrodes are non-sterile and are for single patient use only

Surface electrodes are the interface medium between neurodiagnostic equipment and the patient When used for detection, they transduce broelectric signals into electronic signals for measurement of bioelectrical phenomena in the body, such as peripheral nerve or muscle responses When used in conjunction with stimulation circuitry in neurodiagnostic devices. they provide the interface necessary to stimulate perspheral nerves Surface electrodes are used in the performance of nerve conduction studies (NCS) They are provided non-stertle and are designed and intended to be for single patient use only and are disposable - 트 UNIVERSAL Multi-Electrode Set A (UE-004) - 0 UNIVERSAL Multi-Electrode Set B (UE-005) These individually placed electrodes are not configured for specific nerves. limbs, or clinical applications They may be repositioned on the same patient up to four times Both of the Multi-Electrode Sets include two surface electrodes in a bar configuration for perspheral nerve stumulation, two pars of recording electrodes for measurement of broelectrical potentials, and a reference electrode The par of recording surface electrodes in Multi-Electrode set A (UE-004) are distinct with one arranged as ring electrodes In Multi-Electrode Set B (UE-005), three surface electrodes are used to create two recording pars by sharing of one of the electrodes All of the surface electrodes in the Multi-Electrode Sets are individually placed by The UNIVERSAL Electrodes include an embedded digital thermometer for the user measurement of skin-surface temperature, and a ruler (as part of the graphics layers) for the measurement of inter-electrode distances that are used for calculating conduction velocities