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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.

Note: "Same" in the table indicates that the characteristic matches the predicate device. "N/A" means the characteristic is not applicable to that specific modality for the predicate device as presented in the provided text.

The rationale for substantial equivalence is that the differences in the IF 3Wave (e.g., three output modes instead of one, automatic overload trip, wider range of treatment times and programming options, compliance with voluntary standards, lithium-ion battery) do not raise new questions of safety or effectiveness.

2. Sample Size for the Test Set and Data Provenance:

Not applicable. This is a 510(k) submission based on substantial equivalence to predicate devices, focusing on technical specifications and indications for use, not a clinical study with a "test set" of patients.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. No ground truth for a test set was established as no clinical study was performed for this 510(k) submission.

4. Adjudication Method for the Test Set:

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. No MRMC study was conducted. This type of study demonstrates the clinical utility and impact of AI, which is not relevant for a device cleared through substantial equivalence to existing stimulators.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a powered muscle stimulator, not an AI algorithm. Its performance is evaluated based on its physical and electrical characteristics and comparison to predicate devices, not on algorithmic outputs.

7. Type of Ground Truth Used:

Not applicable. Instead of "ground truth," the basis for equivalence is the well-established safety and effectiveness of the predicate muscle stimulator devices. The "truth" is that these types of devices are already legally marketed and have known performance characteristics.

8. Sample Size for the Training Set:

Not applicable. There is no AI model or algorithm being trained as part of this submission. The device itself is a hardware product.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

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