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

EMS(Electrical Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

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TENS:
The device is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and feet, due to strain from exercise or normal household and work activities.

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

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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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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.

EMS: The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance. The device is designed to temporarily increase local blood circulation in healthy leg muscles.

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The provided FDA 510(k) Clearance Letter for Shenzhen Yicai Health Technology Co. Ltd's Transcutaneous Electrical Nerve Stimulator (TENS) does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI/ML medical device.

This document is a standard clearance letter for a physical medical device (TENS/EMS) and focuses on regulatory aspects like:

• Substantial equivalence to predicate devices.
• General controls (registration, listing, GMP, labeling, misbranding).
• Quality System (QS) regulation.
• Unique Device Identification (UDI) requirements.
• Indications for Use.

It does not detail performance studies conducted to establish effectiveness or safety beyond establishing substantial equivalence to a predicate. Specifically, it lacks any mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) studies or effect sizes for human readers.
• Standalone algorithm performance.
• Type of ground truth used.
• Training set sample size or ground truth establishment for training.

Therefore,Based on the provided FDA 510(k) clearance letter, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the manner requested. The letter is for a physical medical device (Transcutaneous Electrical Nerve Stimulator) and outlines its regulatory clearance, not the details of a performance study, especially not one applicable to an AI/ML device as your detailed questions suggest.

The document does not contain any information related to:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
6. If a standalone (algorithm only) performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

This is a clearance letter for a device whose mechanism of action is electrical stimulation, not an AI/ML algorithm. The information you are seeking would typically be found in the 510(k) summary or the full submission, which are not included in this clearance letter.

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1) 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.

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

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I am sorry, but the provided text from the FDA 510(k) clearance letter for the "3 in 1 TENS UNIT" (K251187) does not contain any information about acceptance criteria or the specifics of a study proving the device meets those criteria, particularly not for an AI/ML medical device.

The document is a standard FDA clearance letter for a Class II medical device (Transcutaneous Electrical Nerve Stimulator For Pain Relief). It primarily covers:

• Device Identification: Trade name, regulation number, product code.
• Regulatory Status: Declaration of substantial equivalence to a predicate device.
• General Controls: Mentions requirements like annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding/adulteration.
• Additional Controls: Notes potential for special controls for Class II devices and references regulations like the Quality System (QS) regulation.
• Compliance: Reminds the applicant of various other FDA regulations (e.g., UDI Rule, MDR).
• Contact Information: Provides resources for further inquiries.
• Indications for Use: Describes the intended use for TENS (pain relief) and EMS (muscle performance).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The information you're asking for typically comes from the premarket submission itself (which might include detailed validation studies, performance data, and the methodology for establishing acceptance criteria), not from the FDA's clearance letter. This type of detail is particularly crucial for AI/ML-based devices, which this TENS unit is not described as.

If you have a document describing the actual performance study and acceptance criteria for this specific device, please provide it, and I would be happy to help analyze it.

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

EMS(Electrical Muscle Stimulation)/PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

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I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the "TENS AND EMS (TENS and Muscle Stimulator)" device (K243856) does not contain the detailed information necessary to answer your request regarding acceptance criteria and performance study data.

This 510(k) letter is a legal document from the FDA stating that the device has been found substantially equivalent to a legally marketed predicate device. It primarily covers administrative details such as:

• The device name and models
• The applicant's information
• Regulation numbers and product codes
• Regulatory classification (Class II)
• The date of clearance
• General controls provisions (registration, listing, GMP, labeling)
• Information about when new 510(k) submissions might be needed for device changes
• Requirements for Quality System (QS) regulation, UDI rule, and adverse event reporting
• Contact information for the FDA

Crucially, it does not include any technical details about the device's performance, clinical study results, acceptance criteria, or the methodology of studies (e.g., sample size, expert qualifications, ground truth establishment, MRMC studies, or standalone performance). This information would typically be found in the manufacturer's 510(k) submission, which is not publicly available in this FDA clearance letter.

Therefore, I cannot populate the table or provide answers to the specific questions you've asked based on the provided text.

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

EMS(Electrical Muscle Stimulation)/PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

I am sorry, but the provided FDA 510(k) clearance letter for the TENS AND EMS (TENS and Muscle Stimulator) devices (K250360) does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.

This document is a formal clearance letter confirming the substantial equivalence of the device to a legally marketed predicate device. It outlines regulatory information, such as:

• Device name and product codes
• Regulation numbers and regulatory class
• Indications for Use
• Requirements for manufacturing and post-market surveillance (e.g., Quality System regulation, MDR, UDI rule)

It does not include:

• Details on performance studies.
• Specific acceptance criteria used for performance verification.
• Information on study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).

To provide the information you've requested, one would typically need access to the summary of safety and effectiveness data (SSED) or the full 510(k) submission, which are often much more detailed than the public clearance letter.

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

EMS (Electrical Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B)

The provided text is a 510(k) clearance letter from the FDA for a TENS and EMS device (TENS and Muscle Stimulator). This type of letter does not contain the detailed information about the acceptance criteria and study data that would be submitted as part of the 510(k) premarket notification.

A 510(k) clearance signifies that the device is "substantially equivalent" to a legally marketed predicate device. While this process involves demonstrating safety and effectiveness, the FDA approval letter itself does not typically include the specific performance metrics, study designs, sample sizes, or ground truth methodologies that an AI/ML device submission would detail. Those technical details are part of the original submission package, not the clearance letter.

Therefore,Based on the provided FDA 510(k) Clearance Letter for the TENS AND EMS (TENS and Muscle Stimulator) device (K250053), there is no information available regarding the acceptance criteria or the specific study details that would prove the device meets these criteria. The letter is an official notification of clearance, stating that the device is substantially equivalent to a predicate device, and does not contain the detailed technical data typically found in a product's technical file or a clinical study report.

The following information cannot be extracted from the provided document:

1. Table of acceptance criteria and reported device performance: Not present.
2. Sample size used for the test set and data provenance: Not present.
3. Number of experts used to establish ground truth and qualifications: Not present.
4. Adjudication method for the test set: Not present.
5. Multi-reader multi-case (MRMC) comparative effectiveness study details: Not present.
6. Standalone (algorithm-only) performance: Not applicable, as this is a physical device, not an AI/ML algorithm.
7. Type of ground truth used: Not present.
8. Sample size for the training set: Not applicable (not an AI/ML device, so no training set in the typical sense).
9. How ground truth for the training set was established: Not applicable.

The letter focuses on regulatory compliance, outlining the device's classification, applicable regulations (e.g., Quality System regulation, UDI Rule), and general controls. It refers to the device as a "TENS and Muscle Stimulator," which is a traditional physical medical device, not an AI/ML software device. Therefore, the questions related to AI/ML specific studies (like MRMC, training sets, ground truth establishment methods for algorithms) are not relevant to this type of device and would not be found in its 510(k) clearance.

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