Everyway Incontinence Stimulation System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K161349 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 Everyway Incontinence Stimulation System is an electrical, non-implantable stimulator designed to manage urinary incontinence. Classified as a Class II device under FDA regulations (876.5320), it delivers controlled electrical stimulation to help restore bladder function and control involuntary urination.
This system is intended for single-use or reusable applications in clinical settings, including urology and gastroenterology. Supplied sterile or non-sterile based on model variant, it operates outside MRI environments due to its electrical components. Multiple model references (e.g., 3006636961, 1000513601) ensure compatibility with various patient needs, and storage follows manufacturer guidelines to maintain functionality. Authorised under FDA 510(k) clearance and MDR compliance, it adheres to regulatory standards for electrical medical devices.
Frequently asked questions
What clinical specialties is the Everyway Incontinence Stimulation System primarily used in, and how does that relate to its design?
The Everyway Incontinence Stimulation System is primarily used in urology and gastroenterology clinics, as indicated by its advisory committee classification (GU) and medical specialty description. This aligns with its design as a non-implantable electrical stimulator intended to manage urinary incontinence by restoring bladder function, making it relevant for conditions affecting both urinary and lower gastrointestinal systems.
Is the Everyway Incontinence Stimulation System safe to use in an MRI environment, and why?
No, the Everyway Incontinence Stimulation System is not designed for use in MRI environments due to its electrical components. The presence of electrical circuitry could pose risks such as interference, overheating, or potential harm from electromagnetic fields generated during MRI scans, which is explicitly noted in the device description.
How many model references are available for the Everyway Incontinence Stimulation System, and what does this indicate about its versatility?
The system includes multiple model references (over 30 listed, including variants like 3006636961 and 1000513601), suggesting a range of configurations or sizes to accommodate different patient needs. This variety indicates the device is designed to be adaptable for diverse clinical applications while maintaining its core function of managing urinary incontinence.
Are there sterile and non-sterile versions of the Everyway Incontinence Stimulation System, and how should they be stored?
Yes, the Everyway Incontinence Stimulation System is supplied in both sterile and non-sterile variants depending on the model. Storage instructions are provided by the manufacturer to ensure functionality, though specific details (e.g., temperature, humidity, or packaging) are not outlined in the data. Clinicians should follow the manufacturer’s guidelines to maintain device integrity, particularly for sterile versions used in clinical settings.
What regulatory pathways has the Everyway Incontinence Stimulation System undergone, and what does this mean for its use in the U.S.?
The device has been authorized through FDA 510(k) clearance and is compliant with the EU’s Medical Device Regulation (MDR). The FDA 510(k) clearance indicates it is classified as a Class II device (876.5320) and is deemed substantially equivalent to a legally marketed predicate device, meaning it meets U.S. safety and performance standards for non-implantable electrical stimulators used in incontinence management.
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
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 | K161349 | Class II | Active |
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Manufacturer
- Manufacturer
- Everyway Medical Instrument Co., Ltd.
Sources (2)
- FDA 510(k) K161349 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026