Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-50…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K233576 FDA 510(k)
- FDA Product Code
- KPI FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5320 FDA 510(k)
- Regulation Number
- 876.5320 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Konmed Incontinence Stimulation Electrode is a non-implantable electrical stimulator designed for incontinence rehabilitation. It provides electromyographic feedback and electrical stimulation to pelvic musculature, targeting the restoration of neuromuscular control in patients with urinary incontinence.
These single-use, Class II devices are supplied sterile and intended for use in clinical settings such as urology or gastroenterology. The vaginal and rectal probes come in specified model numbers for targeted pelvic floor rehabilitation. Authorised under FDA 510(k) and MDR, they adhere to regulatory standards for electrical medical devices (regulation number 876.5320).
Frequently asked questions
What are the key differences between the vaginal and rectal probe models in the Konmed Incontinence Stimulation Electrode system?
The Konmed system includes separate probe models for vaginal (KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013) and rectal (KM-502, KM-5018) use. These probes are designed for targeted pelvic floor rehabilitation, with each model tailored to the anatomical site for electrical stimulation and electromyographic feedback. The vaginal probes are intended for female patients, while the rectal probes are designed for male patients or alternative access routes, ensuring compatibility with the specific clinical setting (urology or gastroenterology).
Are the Konmed Incontinence Stimulation Electrodes reusable or single-use, and how should they be stored?
The Konmed Incontinence Stimulation Electrodes are single-use devices, supplied sterile for clinical use in urology or gastroenterology settings. Since they are sterile upon packaging, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Always follow the manufacturer’s instructions for storage to maintain sterility and functionality until use.
What regulatory pathways does the Konmed Incontinence Stimulation Electrode follow, and what does this mean for clinicians?
The device is authorized under both FDA 510(k) and MDR (Medical Device Regulation) pathways, confirming compliance with electrical medical device standards (regulation number 876.5320). This means the product has undergone rigorous review by regulatory bodies to ensure safety and performance for non-implantable electrical stimulation in incontinence rehabilitation. Clinicians can rely on its adherence to these standards for clinical use.
How do I determine which model number is appropriate for my patient’s needs?
The appropriate model depends on the patient’s anatomy and clinical indication. For female patients, use the vaginal probes (KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013). For male patients or alternative access, the rectal probes (KM-502, KM-5018) are designed. The selection aligns with the device’s intended use for pelvic floor rehabilitation, ensuring proper stimulation and feedback delivery. Always confirm with the manufacturer or clinical guidelines if unsure.
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: Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM ..., Vaginal Probe KM503 | Probe - konmed.cn, Konmed Incontinence Stimulation Electrode (Vaginal… - FDA.report
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K233576 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Konmed Technology Co., Ltd.
Sources (2)
- FDA 510(k) K233576 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026