Model 418 Series Walkers
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
Identifiers
- 510(k) Number
- K053192 FDA 510(k)
- FDA Product Code
- NXE FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3825 FDA 510(k)
- Regulation Number
- 890.3825 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Model 418 Series Walkers are mechanical walkers made of polyvinyl chloride (PVC) and classified as Class I medical devices under regulation number 890.3825. They are designed for use in physical medicine settings to assist with ambulation and mobility support.
These walkers are supplied as non-sterile, reusable devices and are intended for use in healthcare environments. They have received FDA 510(k) clearance (K053192) and are also authorized under the Medical Device Regulation (MDR). No MRI safety information is provided in the data.
Frequently asked questions
What is the Model 418 Series Walker used for?
The Model 418 Series Walker is designed for use in physical medicine settings to assist with ambulation and mobility support, providing mechanical assistance for patients who need help walking or maintaining balance during rehabilitation or daily movement.
Is the Model 418 Series Walker sterile or non-sterile, and is it intended for single-use or reuse?
The Model 418 Series Walker is supplied as a non-sterile device and is intended for reuse in healthcare environments, meaning it can be cleaned and used multiple times following appropriate infection control protocols.
What materials are used to construct the Model 418 Series Walker, and what regulatory classification does it have?
The Model 418 Series Walker is made of polyvinyl chloride (PVC) and is classified as a Class I medical device under regulation number 890.3825, indicating it is subject to general controls and has undergone FDA 510(k) clearance as substantially equivalent to a predicate device.
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: MJM 418-24 Ambulatory Walkers "400" Series - mustmedical.com, 400 Series - Walkers - Combination transport chair/walker, (18 ..., MJM 418-Or-3Tw Ambulatory Walkers "400" Series - mustmedical.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K053192 | Class I | Active |
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Manufacturer
- Manufacturer
- MJM International Corporation
Sources (2)
- FDA 510(k) K053192 24 fields · synced Sep 21, 2026
- EUDAMED 1 fields · synced May 19, 2026