Everyway Incontinence Stimulation System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K213116 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 stimulator, non-implantable, designed for the treatment of incontinence. It is intended to provide electrical stimulation and neuromuscular re-education for the rehabilitation of weak pelvic floor muscles.
This device is used for the treatment of stress, urge, and mixed urinary incontinence in women and to maintain urinary continence in women. It is supplied as a non-implantable system and has received FDA 510(k) clearance under K213116, with classification as a Class II device under regulation number 876.5320.
Frequently asked questions
What is the Everyway Incontinence Stimulation System used for?
It is designed to provide electrical stimulation and neuromuscular re-education for the rehabilitation of weak pelvic floor muscles, specifically to treat stress, urge, and mixed urinary incontinence in women and to maintain urinary continence.
How is the Everyway Incontinence Stimulation System supplied and is it implantable?
The device is supplied as a non-implantable system, meaning it is worn externally and does not require surgical implantation for use in pelvic floor muscle rehabilitation.
What regulatory clearance does the Everyway Incontinence Stimulation System have?
It has received FDA 510(k) clearance under submission number K213116 and is classified as a Class II medical device under regulation 876.5320 for electrical stimulators used in incontinence treatment.
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: EM2400 | DEVICE | Everyway Rehabilitation Bed ... - Everyway Medical, EVERYWAY MEDICAL INSTRUMENTS CO., LTD. Rehabilitation Bed, Electric ..., Everyway Incontinence Stimulation System (K161349) — FDA 510(k ..., Everyway Incontinence Stimulation System (K213116) — FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213116 | Class II | Active |
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Manufacturer
- Manufacturer
- Everyway Medical Instruments Co., Ltd.
- FDA Applicant
- Everyway Medical Instruments Co.,Ltd
Sources (1)
- FDA 510(k) K213116 24 fields · synced Oct 6, 2026