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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 or facilitate muscle performance.

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets such criteria.

The document is a clearance letter from the FDA for a "Wireless TENS & EMS Unit" (K243763). It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls, regulations, and reporting requirements for the manufacturer. It also includes the "Indications for Use" for the device.

However, it does not describe any specific performance acceptance criteria for the device, any study conducted to demonstrate that the device meets those criteria, or any details related to sample sizes, data provenance, expert qualifications, ground truth, or MRMC studies.

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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.

Ask a specific question about this device