# K973537: Pathway Electromyograph

- Pathway: 510(k) (Traditional)
- Applicant: The Prometheus Group
- Decided: Dec 17, 1997 after 90 days
- Product code: HCC (Device, Biofeedback)
- Device class: 2
- Regulation: 21 CFR 882.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
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 Kegel 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.

Source page: https://510kreport.com/device/K973537
Methodology: https://510kreport.com/methodology