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Transcutaneous Electrical Nerve Stimulator (Model: RJTENS-2) can be used for the symptomatic relief of chronic intractable pain, post traumatic pain adjunctive treatment, and post-surgical pain adjunctive treatment.

Transcutaneous Electrical Nerve Stimulator (Model: RJTENS-2) sends gentle electrical current to underlying nerves and muscle groups via electrodes applied onto the skin to relieve pain. The device has 14 programs (11 standard programs and 3 editable programs). It is a lithium battery-powered device comprising the electronic stimulatory module, the accessories of lead wires, the electrodes and the adapter. Two outlet sockets are used to connect skin electrodes by lead wires. The accessories of electrodes are 510(k) cleared devices (K213879). Size: 50*50mm.

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1. The Z4 Li-Battery Powered OTC TENS/EMS Combination Stimulator is intended for over-the-counter (OTC) use. It integrates both TENS and EMS functions in a single unit. However, the device can only operate in one mode (either TENS or EMS) at a time; simultaneous operation of both modes is not possible.

2. TENS is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. (Choose TENS Modes P1 to P19 programs)

3. EMS is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. (Choose EMS Modes P20 to P30 programs)

The Li-Battery powered OTC TENS/EMS Combination Stimulator, model Z4, is a four-channel electrical stimulation device intended for pain relief and muscle training. It delivers electrical current through electrodes placed on the user's skin. Each operating mode delivers a fixed, pre-configured waveform (e.g., asymmetrical bi-phasic square pulse) and output characteristics; users may only adjust intensity and treatment duration within predefined limits.

The device primarily consists of two components: the stimulation generator and adhesive electrodes. The generator produces the stimulation current, which is delivered to the body via lead wires connected to the electrodes. Depending on the selected mode—TENS or EMS—the device helps achieve either temporary pain relief or improved muscle performance.

The Z4 includes the following preset programs:

• TENS Mode (Programs P1–P19): Intended for temporary relief of pain in the lower back, arms, and legs due to exercise or household/work strain. Users are advised to begin with the lowest intensity and gradually increase to a comfortable "tingling" sensation. Each program differs in waveform parameters and may produce varied sensations.

• EMS Mode (Programs P20–P30): Designed to stimulate healthy muscles to enhance or support muscle performance. These programs cause the muscles to contract and relax. Users should start at low intensity for warm-up and increase gradually as needed.

The Z4 device package includes the following accessories:

• Adhesive Electrode Pads × 24
• Lead Wires × 4
• USB Cable × 1
• Instruction Manual × 1
• Carrying Case × 1

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TENS: The device is designed to be used for temporary relief of pain associated with the sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

The Globus Triathlon Pro TENS and EMS stimulator is an over-the-counter transcutaneous electrical nerve stimulator and electronic muscle stimulator (TENS/EMS) device providing peripheral nervous system stimulation and muscular electrostimulation in order to reduce atrophy, spasticity, and to increase muscular power. It can be used for arm, shoulder, neck, back, waist, abdomen, and legs.

The stimulation channels transfer the desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing muscle contractions. The accessory electrodes are FDA-cleared. They are used as an accessory to the TENS or EMS device unit, which transmits electrical current to the patient skin. The electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin.

The Triathlon Pro provides electro stimulation through the surface electrodes. Electrode position during electro stimulation depends on the body part involved and on the type of program that is being carried out. For all programs that cause significant muscle contraction, it is important to place the electrode on the muscle motor point, which is the most sensitive to stimulation. The electro stimulator keeps track of the last 10 executed programs so that they are available for very simple and fast execution. Recording takes place automatically at the end of the execution of a program.

Electrostimulations are designed to be used in domestic environments, clinics, physiotherapy centers, rehabilitation in general, pain treatments in general, for aesthetic and sport purposes. The user of this device must be adult.

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The Medi Lift Essential Eye Mask is intended for facial stimulation and indicated for over-the-counter cosmetic use.

The Medi Lift Essential Eye Mask ("Medi Lift Eye") is composed of a mask made of silicone rubber which is worn on the upper part of the user's face, and covers the upper cheek and the periocular region outside the orbital rim. The mask contains two controllers with electrodes, which are attached to the mask. These controllers and electrodes deliver electrical pulses to stimulate facial muscles. The controllers are operated independently by pressing buttons on each controller. The mask also contains a heater to warm the upper cheek area for user relaxation, not for a medical purpose. The stimulation and heating functions are provided in separate modes and cannot be used simultaneously. The controllers attached to the mask contain two charging pins which allow for the built-in Lithium-ion battery that powers the device to be charged using a USB charging cable that is provided as part of the device. The device is not operated during charging.

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JOVS Electric Stimulation Beauty Device is indicated for over-the-counter aesthetic use including facial and neck stimulation.

The JOVS Electric Stimulation Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It mainly consists of main unit, charging and disinfection base, and power cable. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging. The device is only home environment use, which has the spring electrode head (electric stimulation) to provide the following function:

The JOVS Electric Stimulation Beauty Device is indicated for over-the-counter aesthetic use including facial and neck stimulation.

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The MEGELIN LED Light Therapy Mask is an Over-the-Counter (OTC) light based device.

• Red light: Treatment of full-face wrinkles.
• Blue light (only suitable model JML1, JML3, JML5, JML6, JML9 Face mask): Treatment of mild to moderate inflammatory acne.

The MEGELIN LED Light Therapy Mask uses blue light (460nm) to treat acne. The MEGELIN LED Light Therapy Mask uses red light (660nm) to irradiate on the facial skin that help reduce wrinkles.

JML1, JML3, JML5, JML6, JML9 are face masks, with the only difference in energy density setting, while JML2, JML4, JML7, JML8, JML10 are neck masks with the only difference in energy density setting.

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Facial & Body Beauty Device is a hand-held device for over-the-counter aesthetic purposes.
The Microcurrent stimulation mode is indicated for facial skin stimulation and body skin stimulation.

Facial & Body Beauty Device is portable, non-sterile and reusable device, which is designed to achieve the aesthetic effect. The device mainly consists of a main unit and charging cable, and it is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the provided charging cable, but the device can not be used when charging. To use the device, user should place the electrode head on the face and body. The device will automatically shut down after treatment time is over.

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Low Frequency Electric Stimulator: This Device uses microcurrent electrical to stimulate facial tissues for aesthetic purposes.

The Sunny Plus device is a Low Frequency Electric Stimulator that conveys current to the human body through a non-invasive electrode with a frequency of 10Hz. It is composed of the main body, handpiece with electrode tip, and foot switch. The device is operated through a graphic user interface on an LCD screen and is intended to be operated by medical professionals.

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The SX2500 / SX3800 Series devices uses microcurrent electrical energy to stimulate facial tissues for aesthetic purposes.

The subject devices, SX2500 & SX3800, under the NFO Product Code, uses microcurrent electrical energy to stimulate facial tissues for aesthetic purposes. The SX series uses applied accessories like probes, gloves or pads to deliver low electrical current to stimulation of facial tissues for aesthetic purposes.

The SX2500 & SX3800 is a powered microcurrent stimulator that uses electrical energy to stimulate facial tissues for aesthetic purposes. The SX2500 & SX3800 is substantially equivalent to the predicate devices compared in its product code class and has the same IFU. The SX2500 & SX3800 delivers signals independently to specific facial area points by way of channel ports via stainless steel probes and applicators substantially equivalent to the predicate device. The probes, gloves and pads referenced are the only patient contacting parts on the device that is substantially equivalent to the predicate device.

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Transcutaneous Electrical Nerve Stimulation (TENS):
The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.

Electrical Muscle Stimulation (EMS):
The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

Not Found

I am sorry, but the provided FDA 510(k) Clearance Letter for the "OTC 4-Channel Rechargeable TENS Unit" (K251429) does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.

This document is a clearance letter, which means the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It focuses on the regulatory aspects of the clearance, such as:

• Device name and regulation
• Regulatory class and product code
• Substantial equivalence determination
• General controls and additional controls applicable to the device
• References to FDA guidance documents and regulations (e.g., Quality System regulation, UDI Rule)
• Contact information for the FDA

Specifically, the document does NOT include:

1. A table of acceptance criteria and reported device performance: This type of data would typically be found in the actual 510(k) submission, not the clearance letter.
2. Sample size used for the test set and data provenance: Again, this is detailed information from the testing portion of the submission.
3. Number of experts and their qualifications for establishing ground truth: Not mentioned in this regulatory letter.
4. Adjudication method: Not applicable or mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results: This applies to AI/CAD devices, and the TENS unit is a physical device, so such a study would not be relevant.
6. Standalone (algorithm only) performance: Not applicable for a TENS unit.
7. Type of ground truth used: Not applicable or mentioned.
8. Sample size for the training set: Not applicable for a TENS unit (unless it incorporates some form of adaptive AI, which is not indicated here).
9. How the ground truth for the training set was established: Not applicable for a TENS unit.

The provided text only states the Indications for Use for the TENS and EMS functions. To find the specific performance data and acceptance criteria, you would need to access the full 510(k) submission (if it were publicly available in that format, which it generally is not for the detailed technical reports). The clearance letter confirms that the FDA reviewed such data and found it adequate for substantial equivalence, but it does not reproduce that data.

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