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Conductive carbon film electrode are cutaneous electrodes to be used with legally marketed TENS, EMS or NMES devices. The Conductive carbon film electrodes are non-sterile reusable conductive garments that are intended to deliver the pulses generated by the electrotherapy stimulator to the body surface with which they are in contact. These body parts can include the upper limb including wrist and hand, elbow or shoulder, lower and upper back, lower limb including hip, knee, leg, ankle and feet, and the back of the neck.

Conductive carbon film electrode are cutaneous electrodes to be used with legally marketed TENS, EMS or NMES devices. The Conductive carbon film electrodes are non-sterile reusable conductive garments that are intended to deliver the pulses generated by the electrotherapy stimulator to the body surface with which they are in contact.

I apologize, but the provided text from the FDA 510(k) clearance letter for the "Conductive carbon film electrode" does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.

The document is a standard FDA clearance letter confirming that the device is substantially equivalent to a predicate device and can be marketed. It details the device name, product code, regulation number, and indications for use. It also outlines general regulatory requirements.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This information would typically be found in the 510(k) submission itself, which is not fully included here.

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