FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Surface electromyography is a safe and effective technique for relaxation training and muscle re-education. Using internal perineometer electrodes such as the PerryVaginal: EMG biofeedback is a safe and effective technique for the assessment and treatment of pelvic floor dysfunction, monitoring the performance of Keyel exercises. The pelvic floor muscles include the Levator Ani group as well as the pubococcygeus (PC), ileococcygeus, and coccygeus. These are skeletal muscles which respond to re-education, strengthening, endurance building, and relaxation. Conditions that can be assessed or treated using this technique include: stress incontinence, mixed incontinence, and urge incontinence.

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The provided text is a 510(k) clearance letter from the FDA for a device called "Pathway TR-10, TR-10C, TR-20, TR20C." This document does not contain details about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter focuses on the FDA's determination of substantial equivalence to a predicate device and outlines regulatory obligations for the manufacturer. The "Indications for Use" section describes what the device is intended for, but not how well it performs or how that performance was validated.

Therefore, I cannot provide the requested information based on the given input.

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K Number

K960508

Device Name

PATHWAY ELECTROMYOGRAPH MODEL PATHWAY II/MR-10/MR-15/MR-20/MR-25

Manufacturer

THE PROMETHEUS GROUP

Date Cleared

1997-01-16

(346 days)