Search Results

Over-The-Counter Use:

TENS:

To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, wast, back, arm,and leg, due to strain from exercise or normal household and work activities.

EMS/NMES:

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Prescription Use:

TENS:

1)Symptomatic relief of chronic intractable pain; 2)Post traumatic pain; 3)Post surgical pain;

EMS/NMES:

1)Relaxation of muscle spasm;

2)Increase of local blood flow circulation;

3)Prevention or retardation of disuse atrophy;

4)Muscle re-education:

5)Maintaining or increasing range of motion;

6)Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Not Found

The provided text is an FDA 510(k) clearance letter for a Wireless TENS & EMS device. It does not contain information on the acceptance criteria, study details, or performance metrics often found in a clinical study report. Therefore, I cannot generate the requested table and answer the study-related questions based on this document.

The document primarily focuses on:

• The FDA's decision of substantial equivalence.
• The indications for use for the device.
• Regulatory information and requirements.

To answer your questions, I would need a clinical study report or a summary of safety and effectiveness data, which typically includes performance testing and results.

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The SM9027 Smart Muscle Training Wearables is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen, arms and thighs.
The SM9037 Smart Muscle Training Wearables is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen, arms and thighs.
The SM9566 Smart Muscle Training Wearables is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen, arms and thighs.
The SM9065N Smart Muscle Training Wearables is intended for use by healthy persons to apply transcutaneous electrical muscle stimulation (EMS) through skin contact electrodes for the following purposes: - Improvement of muscle tone of the muscles in the abdomen, arms and thighs.

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study design, or ground truth establishment. The document is an FDA 510(k) clearance letter for Smart Muscle Training Wearable devices, outlining their indications for use and regulatory compliance. It does not include details of a clinical study or performance evaluation with specific metrics.

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For Over-The-Counter Use:

TENS:

SM9075 (mode 1-24), SM9910 (mode 1-8), SM9067 (mode 1-9), SM9587W (mode 1-8) are used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leq, due to strain from exercise or normal household and work activities.

SM9075 (mode 1-24), SM9910 (mode 1-8), SM9067 (mode 1-9), SM9587W (mode 1-8) are also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

PMS/NMES:

SM9075 (mode 25-48, 49-60), SM9910 (mode 9-16, 17-24), SM9067 (mode 10-18, 19-36), SM9587W (mode 9-18, 19-24) are used to stimulate healthy muscles in order to improve and facilitate muscle performance.

To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases.

SM9075 (mode 25-48), SM9910 (mode 9-16), SM9067 (mode 10-18), SM9587W (mode 9-18) are also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.

For Prescription Use:

TENS:

SM9075 (mode 1-24), SM9910 (mode 1-8), SM9067 (mode 1-9), SM9587W (mode 1-8) are intended for the following use:

• Symptomatic relief and management of chronic, intractable pain
• Adjunctive treatment for post-surgical and post-trauma acute pain
• Relief of pain associated with arthritis

PMS/NMES:

SM9075 (mode 25-48, 49-60), SM9910 (mode 9-16, 17-24), SM9067 (mode 10-18, 19-36), SM9587W (mode 9-18, 19-24) are intended for the following use:

• Temporary relaxation of muscle spasm

• Prevention or retardation of disuse atrophy

• Muscle re-education

• Maintaining or increasing range of motion

• Increase of local blood flow in the treatment area

• Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a Pain Therapy Device. This document does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. This type of information would typically be found in the 510(k) submission itself or in a separate study report, which is not included in the provided input.

Therefore, I cannot fulfill your request for the tables and study details based on the given text.

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

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device named "TENS7000 Rechargeable." This document confirms the device's substantial equivalence to a predicate device and outlines regulatory requirements.

However, the letter does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria. It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness study results (effect size).
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size or ground truth establishment for a training set.

The document primarily focuses on regulatory approval based on substantial equivalence to a legally marketed predicate device, rather than detailed performance study results against specific acceptance criteria.

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