Pathway Vaginal/Rectal Perineometer Probe
by The Prometheus Group 510(k)
Active
510(k) K974036
Overview
The Pathway Vaginal/Rectal Perineometer Probe is a perineometer designed to measure the electromyographic activity of pelvic musculature. It functions as an intracavity sensor for assessing muscle strength and neuromuscular control, aiding in the rehabilitation of weakened pelvic muscles. This device is specifically categorized as a perineometer, a tool used to evaluate pelvic floor function through electrical signal detection.
The probe is intended for use with compatible EMG units, such as the Pathway NMR, MR, or TR Series, via a universal adapter. It is supplied as a single-use or reusable device, depending on manufacturer guidelines, and is regulated under FDA 510(k) clearance (K974036) as a Class II medical device (regulation number 884.1425). The probe is designed for obstetrics and gynecology applications, adhering to standard clinical practices for pelvic floor assessment. Storage and handling follow manufacturer instructions to maintain device integrity.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK974036 | Date22 Dec 1997 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- HIR
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.1425
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Other devices from The Prometheus Group
Questions
What is the Pathway Vaginal/Rectal Perineometer Probe used for?
The Pathway Vaginal/Rectal Perineometer Probe is designed to measure electromyographic (EMG) activity of pelvic musculature. It functions as an intracavity sensor to assess muscle strength and neuromuscular control, which is critical for evaluating pelvic floor function. This is particularly useful in the rehabilitation of weakened pelvic muscles, often encountered in obstetrics and gynecology.
Which EMG units is this probe compatible with?
The probe is intended for use with compatible EMG units, specifically the Pathway NMR, MR, or TR Series. It connects via a universal adapter, ensuring compatibility with these systems for accurate pelvic floor assessment.
Is the Pathway Vaginal/Rectal Perineometer Probe single-use or reusable?
The Pathway Vaginal/Rectal Perineometer Probe can be supplied as either single-use or reusable, depending on the manufacturer’s guidelines. Proper storage and handling are essential to maintain device integrity, whether it is used once or multiple times, as outlined in the manufacturer’s instructions.
What regulatory status does this device hold?
The Pathway Vaginal/Rectal Perineometer Probe holds FDA 510(k) clearance (K974036) and is classified as a Class II medical device under regulation number 884.1425. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards.
How should the probe be stored to ensure proper functionality?
The probe should be stored according to the manufacturer’s instructions to maintain its integrity. Proper storage conditions help preserve its functionality and ensure accurate readings during pelvic floor assessments. Always follow the guidelines provided by The Prometheus Group to avoid contamination or damage.