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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.

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