(91 days)
Electrically powered devices intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.
Indications For Use include:
- 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 Rhythm Touch Q 2-Way is a dual channeled powered muscle stimulator. It electronically stimulates muscles. It comprises two main components, namely, an electronic stimulatory module which generates the required stimulation signals, and skin electrodes with lead wires.
The product is supplied with a set of single sided adhesive electrodes, an instruction manual, and a set of batteries. Power is derived from two AAA cells located in a compartment protected by a removable battery cover.
The electrodes, which are provided with this model, have 510(k) clearance. They are 2" x 2" in size. The leadwires also have 510(k) clearance.
The provided text is a 510(k) summary for the Rhythm Touch Q 2-Way, an electrical muscle stimulation device. It establishes substantial equivalence to a predicate device (BioStim Digital NMS) based on similar technological characteristics and intended use.
No information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training or test sets is present in the provided document.
This document is a regulatory submission for device clearance, focusing on comparing the new device to a legally marketed predicate to demonstrate substantial equivalence, rather than detailing performance studies and acceptance criteria as would be found in a clinical or performance study report.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text.
§ 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).