(139 days)
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:
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Temporary relaxation of muscle spasm
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Prevention or retardation of disuse atrophy
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Muscle re-education
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Maintaining or increasing range of motion
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Increase of local blood flow in the treatment area
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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.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).