(129 days)
- Specific indications: used to apply an electrical current to electrodes on patient's skin to function as:
Relaxation of muscle spasms;
Prevention or retardation of disuse atrophy
Muscle re-education
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Maintaining or increasing range of motion.
- Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.
Not Found
There is no information in the provided text about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) clearance letter from the FDA for a powered muscle stimulator, indicating substantial equivalence to a predicate device. It does not contain details about performance studies or acceptance criteria.
The information provided consists of:
- FDA 510(k) Clearance Letter: This letter confirms that the Sun-Tens Palm Type R5/Compact Wireless M2 EMS Series device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.
- Indications for Use: The letter includes an enclosure detailing the intended uses of the device, which are relaxation of muscle spasms, prevention or retardation of disuse atrophy, muscle re-education, immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, and maintaining or increasing range of motion. It also specifies that the device should only be used under medical supervision for adjunctive therapy.
To answer your request, a detailed performance study report with acceptance criteria would be needed, which is not present in this document.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).