(90 days)
This device is a prescription device and only for symptomatic relief of chronic intractable pain.
Relaxation of muscle spasms.
Prevention or retardation of disuse atrophy.
Increasing local blood circulation.
Muscle re-education.
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Maintaining or increasing range of motion.
The Digi-Pro TENS series, including WL-2203, WL-2204, and WL-2205 are transcutaneous r he Dig TTO reason of sed for pain relief and/or powered muscle stimulator by applying an electrical norrent to electrodes, which are attached on the patient's skin. The output and waveform is adjustable according to the situation of patient.
Digi-Pro TENS series, models WL-2203, WL-2204, and WL-2205, consist mainly of two parts: Digit to TENO benerator, electrode. The stimulus generator generates the output current specified the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief.
The stimulation mode for Digi-Pro TENS includes several different operation modes as mentioned on the comparison table. These operation modes are generated from the software control by using the microprocessor as its main control unit.
The provided text is a 510(k) summary for a Transcutaneous Electrical Nerve Stimulation (TENS) device. It describes the device, its intended use, and provides some regulatory information, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.
The document is a submission for a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish strict performance against predefined acceptance criteria through clinical studies in the same way a PMA (Premarket Approval) submission might.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study from the provided text. The document focuses on device description, intended use, and regulatory classification.
§ 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).