(214 days)
For VMS, Russian, Monophasic Hi-Volt
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
- Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For Microcurrent, Interferential and Premodulated - Symptomatic relief of chronic, intractable pain
- Management of pain associated with post-traumatic or post-operative conditions
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Vectra 2C, 4C, 2S, 4S, Pro 2, and Pro 4). This document does not contain any information about acceptance criteria, device performance, study designs, sample sizes, ground truth establishment, or expert qualifications.
The letter primarily indicates that the devices are substantially equivalent to pre-amendment devices and can be marketed subject to general controls. It lists the indications for use of the devices but does not provide details on studies that support these indications or specific performance metrics.
Therefore, I cannot fulfill your request for the detailed information on acceptance criteria and study data based on the provided 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).