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• Relaxation of muscle spasm .
• Increasing local blood circulation .
• Maintaining or increasing range of motion •
• Preventing or retarding disuse atrophy .
• Muscle re-education .
• Intusion is outcales. .

CS3102 High Voltage Galvanic Stimulator

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA for a device called the "CS3102 High Voltage Galvanic Stimulator." It outlines the device's indications for use and confirms its substantial equivalence to legally marketed predicate devices.

The document does not include:

• A table of acceptance criteria and reported device performance.
• Details about a study, sample sizes, data provenance, expert qualifications, or adjudication methods for establishing ground truth.
• Information about MRMC comparative effectiveness studies or standalone algorithm performance.
• Details on how ground truth was established for training or test sets.

Therefore, I cannot fulfill your request based on the provided input.

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• . Interferential Current Therapy Modes: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.
• Neuro-Muscular Stimulator Modes: Relaxation of muscle spasm, increasing local blood circu-. lation, maintaining or increasing range of motion, preventing or retarding disuse atrophy, muscle re-education, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the CS3101 Interferential Stimulator. This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The letter primarily:

• Acknowledges receipt and review of the 510(k) submission (K993420).
• States that the device is substantially equivalent to legally marketed predicate devices.
• Grants permission to market the device subject to general control provisions.
• Lists the Indications for Use for the CS3101 Interferential Stimulator.

Therefore, I cannot provide the requested table and study details based on the input text. The information needed to answer your questions would typically be found in the 510(k) submission itself, particularly in the sections describing performance testing and clinical data (if applicable), which are not present in this clearance letter.

Ask a specific question about this device