SRS Vaginal EMG/Stimulation Perineometer Sensor SRS Anal EMG/Stimulation Perineometer Sensor
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K002834 FDA 510(k)
- FDA Product Code
- HIR FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 884.1425 FDA 510(k)
- Regulation Number
- 884.1425 FDA 510(k)
- Advisory Committee
- Obstetrics/Gynecology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SRS Vaginal EMG/Stimulation Perineometer Sensor and SRS Anal EMG/Stimulation Perineometer Sensor are medical devices classified as perineometers. These sensors are designed to measure and stimulate pelvic floor muscle activity, providing electromyographic (EMG) feedback and electrical stimulation to assess and train perineal muscle function, particularly in obstetrics and gynecology applications.
These sensors are intended for use in clinical settings, such as obstetrics and gynecology practices, to evaluate and rehabilitate pelvic floor dysfunction. They are non-implantable, reusable devices and are regulated under FDA 510(k) clearance (K002834) as Class II devices under the product code HIR. The devices are not sterile and require proper cleaning and maintenance between uses. No MRI safety information is specified in the available data.
Frequently asked questions
What are the SRS Vaginal and Anal EMG/Stimulation Perineometer Sensors used for?
These sensors measure and stimulate pelvic floor muscle activity via electromyographic (EMG) feedback and electrical stimulation. They are designed for clinical use in obstetrics and gynecology to evaluate and rehabilitate pelvic floor dysfunction, such as incontinence or weakness, by providing real-time assessment and targeted muscle training.
Are the SRS Perineometer Sensors single-use or reusable?
The SRS Perineometer Sensors are reusable devices. They are intended for repeated use in clinical settings, but require proper cleaning and maintenance between patients to ensure hygiene and functionality. The manufacturer specifies they are not sterile and must be handled according to established disinfection protocols.
What regulatory approval does the SRS Perineometer Sensor hold?
The SRS Vaginal and Anal EMG/Stimulation Perineometer Sensors are cleared by the FDA under 510(k) (K002834) as Class II devices under product code HIR. This clearance confirms their substantial equivalence to a predicate device and compliance with U.S. regulatory standards for obstetrics/gynecology applications.
How should the SRS Perineometer Sensors be stored?
While specific storage instructions are not detailed in the provided data, reusable medical devices like these typically require clean, dry storage in a protected environment to prevent contamination or damage. Follow manufacturer guidelines for disinfection and maintenance to ensure proper functionality and longevity.
Are there different models or sizes available for the SRS Perineometer Sensors?
The SRS Perineometer Sensors include both vaginal and anal variants, each designed for specific anatomical use. Multiple registration numbers (e.g., 3006636961, 3013426279) suggest variations may exist, but exact sizing or model-specific differences (e.g., sensor shape, stimulation intensity) are not detailed in the provided data. Contact the manufacturer for precise specifications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Srs Vaginal Emg/Stimulation Perineometer Sensor Srs Anal Emg ..., 510 (k) K002834 — SRS VAGINAL EMG/STIMULATION PERINEOMETER SENSOR SRS ..., SRS VAGINAL EMG/STIMULATIO… — K002834 · DeviceClearance, K993976 FDA 510(k) - PATHWAY VAGINAL EMG/STIM PERINEOMETER S...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K002834 | Class II | Active |
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Manufacturer
- Manufacturer
- SRS Medical Systems, Inc.
Sources (1)
- FDA 510(k) K002834 24 fields · synced Oct 5, 2026