(67 days)
This device is a 'combination' device and has the same indications for use as two different types of predicate devices.
High Volt Pulsed Galvanic Stimulators and Neuromuscular Electrical Stimulators share the same indications for use as listed below.
- 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 ●
Interferential Stimulators have one additional indication for use:
Symptomatic relief of chronic intractable pain and as an adjunctive treatment in the management of post traumatic and post-surgical pain relief.
Not Found
This document is a 510(k) clearance letter from the FDA for a device named "Surgi Stim". It confirms that the device is substantially equivalent to predicate devices and can be marketed. However, this document does not contain any information regarding acceptance criteria, device performance results, sample sizes, ground truth establishment, or details of a study that proves the device meets specific performance criteria.
The letter focuses on the regulatory clearance process and states the "Indications For Use" for the Surgi Stim device which is a combination of High Volt Pulsed Galvanic Stimulators, Neuromuscular Electrical Stimulators, and Interferential Stimulators.
Therefore, I cannot answer your specific questions based on the provided text. The document does not describe a study or provide performance data.
§ 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).