(170 days)
The VEINOPLUS® Neuromuscular Stimulator is indicated for the following:
In the Primary Mode of Action (PMOA) when the Operating Mode number 1 for muscle stimulation is activated, the Indications for Use are:
- · Relaxation of muscle spasms.
- · Prevention or retardation of muscle 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.
In the other Mode of Action (MOA), when the Operating Mode number 2 for Transcutaneous Electrical Nerve Stimulation (TENS) stimulation is activated, the Indication for Use is :
· Providing symptomatic pain relief for chronic, acute or post operative pain.
The VEINOPLUS® Neuromuscular Stimulator is a traditional battery powered muscle stimulator and it is combined with the TENS stimulator. It is a single channel device with its Operating Modes stored in the internal memory. The VEINOPLUS® provides two separate and switchable independent Operating Modes of stimulation.
The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. Instead, it is a 510(k) premarket notification for the VEINOPLUS® Neuromuscular Stimulator, outlining its administrative information, description, indications for use, and a comparison to predicate devices for substantial equivalence.
Therefore, I cannot provide the requested table or details regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.
§ 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).