Pelvifine Pelvic Muscle Trainer
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K163288 FDA 510(k)
- FDA Product Code
- KPI FDA 510(k)
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 Pelvifine Pelvic Muscle Trainer is an electrical, non-implantable stimulator designed for incontinence management. Classified as a Class II device under FDA regulations (876.5320), it targets pelvic floor muscle strengthening to improve urinary and fecal continence in patients.
Supplied as a reusable device, the Pelvifine is intended for use in clinical settings such as urology and gastroenterology practices. It operates under FDA 510(k) clearance (K163288) and EU MDD compliance, with no MRI safety restrictions specified. Multiple model variants (e.g., 3006636961, 3013426279) are available, each requiring proper storage and maintenance as per manufacturer instructions.
Frequently asked questions
What medical specialties commonly use the Pelvifine Pelvic Muscle Trainer in clinical practice?
The Pelvifine Pelvic Muscle Trainer is primarily utilized in urology and gastroenterology practices. This is supported by its classification under FDA product code KPI (Stimulator, Electrical, Non-Implantable, For Incontinence) and its advisory committee designation as GU (Gastroenterology, Urology). Clinicians in these fields often recommend pelvic floor muscle stimulation for managing urinary and fecal incontinence.
Is the Pelvifine Pelvic Muscle Trainer intended for single-use or reusable applications, and how should it be maintained?
The Pelvifine is designed as a reusable device for clinical settings. Since it is not single-use, proper storage and maintenance are critical to ensure functionality and hygiene. The manufacturer provides specific instructions for care, which must be followed to avoid contamination or damage. Reuse aligns with its classification as a non-implantable stimulator meant for repeated use in controlled environments like urology or gastroenterology clinics.
What regulatory pathways has the Pelvifine Pelvic Muscle Trainer followed, and how does this affect its availability?
The Pelvifine has undergone FDA 510(k) clearance (K163288) and complies with the EU Medical Device Directive (MDD). Its classification as a Class II device under FDA regulation (876.5320) and the traditional 510(k) pathway indicate it has been deemed substantially equivalent to a predicate device. This regulatory route ensures its availability in markets adhering to these standards, including the U.S. and EU, for use in incontinence management under clinical supervision.
Are there multiple models of the Pelvifine available, and how do I identify the correct variant for my needs?
Yes, the Pelvifine comes in multiple model variants, including identifiers like 3006636961, 3013426279, and others listed in the registration records. While the core function remains the same—pelvic floor muscle stimulation for incontinence—the specific model may vary based on technical specifications or regional compliance requirements. To select the correct variant, consult the manufacturer’s documentation or contact Shenzhen Konmed Technology Co., Ltd. for guidance tailored to your clinical setting or patient population.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K163288 | Class II | Active |
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Manufacturer
- Manufacturer
- Shenzhen Konmed Technology Co., Ltd.
Sources (2)
- FDA 510(k) K163288 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026