(183 days)
PAIN MANAGEMENT
Indications for Electromedical Treatment
- For adjunctive treatment of post-traumatic pain syndromes.
- For management and symptomatic relief of chronic (long-term) intractable pain.
- As an adjunctive treatment in the management of post-surgical pain problems.
MUSCLE STIMULATION
Indications for Electromedical Treatment
- Relaxation of muscle spasms.
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle reeducation
- Immediate post-surgical stimulation of calf muscle to prevent phlebothrombosis.
- Maintaining or increasing range of motion
Powered Muscle stimulators should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.
This device is an electrical signal generator which applies sinusoidal current through two pairs of contact electrodes using temporal interference patterns to stimulate peripheral nerves for the purpose of providing pain relief or as an adjunctive treatment in physical therapy per guidelines in the indications for use. As an alternative, this device can perform the forementioned functions by applying sinusoidal current through only one pair of electrodes.
The provided text is a 510(k) summary for the NEO GeneSys 2k, an interferential current therapy device. This document primarily focuses on establishing substantial equivalence to a predicate device (ProElecDT, K930263) and does not contain information about specific acceptance criteria or a study proving the device meets particular performance metrics.
The document states: "There is no difference in technological characteristics between this device and the predicate device." This implies that the substantial equivalence is based on the device having similar technological characteristics and intended use as the predicate, rather than on new performance studies with specific acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided text. The document is an FDA regulatory filing focused on establishing substantial equivalence, not a detailed performance study report.
§ 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).