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Interferential stimulation can be used for the following applications:

• Relieve acute pain .
• . Relieve and manage chronic pain
• Relax muscle spasms .
• Maintain and increase the range of motion .
• Increase local blood circulation .

Neuromuscular stimulation can be used for the following applications:

• Relax muscle spasms .
• Prevent or retard disuse atrophy .
• Increase local blood circulation .
• Re-educate muscles .
• Maintain or increase the range of motion .
• Prevent venous thrombosis using immediate postsurgical stimulation on calf . muscles

Pulsed direct current stimulation can be used for the following applications:

• Reduction of edema (under negative electrode) t
• Reduction of muscle spasm .
• Influencing local blood circulation (under negative electrode) .
• Retardation or prevention of disuse atrophy .
• Facilitation of voluntary motor function .
• Maintenance or increase of range of motion .

Interferential and Neuromuscular combination stimulation can be used for the following applications:

• Reduction of edema (under negative electrode) .
• Reduction of muscle spasm .

The IF 3 Wave is a non-invasive medium/low frequency interferential muscle rie it -> wave is a intended for treating patients that have acute and chronic pain, edema, tight musculature, muscle spasms and muscular weakness due to disuse atrophy. The IF 3 Wave stimulator is a microprocessor controlled dual channel Interferential electro-stimulator with neuro-muscular and pulse direct current micronital expabilities. It will offer 4 separate electro-therapy stimulation modalities. Stimulation capacificies: 17 Will on P), neuromuscular electrical stimulation (NMES), r neso direct current (PDC) electrical stimulation, and a combination of interferential and neuromuscular electrical stimulation (IF/NMES).

The IF 3 Wave will be capable of storing device settings, use, and compliance data for up to 90 days. It will be capable of down loading the above compliance date through a up to 90 days. which is contained within the battery charger base. Once per phone mic modelin, will be instructed to download the stored data from their device, month, the patient will over compliance report which is forwarded to their physicians for which will ereate a paysician will review the report and provide adjustment to the patient treatment regimen and device setting accordingly.

Accessories provided with the IF 3 Wave include lead wires, electrode pads, Accessories proTracu wik, battery charger/modem, phone cable, power supply, and a users manual.

This K510(k) submission describes the IF 3Wave Interferential Muscle Stimulator System, Model 7110S. The submission focuses on establishing substantial equivalence to previously cleared predicate devices rather than reporting on a new clinical study with acceptance criteria.

Therefore, many of the requested sections related to acceptance criteria and study data are not applicable to this 510(k) submission.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) summary demonstrating substantial equivalence, there are no explicit "acceptance criteria" in the sense of predefined thresholds for clinical or diagnostic performance metrics. Instead, the device's technical characteristics are compared to those of its predicate devices to demonstrate equivalence. The "reported device performance" is essentially the listed technical specifications of the IF 3Wave.

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