e-fix E35/E36
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Alber GmbH
Identifiers
- 510(k) Number
- K161241 FDA 510(k)
- FDA Product Code
- ITI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.3860 FDA 510(k)
- Regulation Number
- 890.3860 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The e-fix E35/E36 is a Wheelchair, Powered, designed for mobility assistance. It is a motorised wheelchair intended to provide independent or assisted transport for individuals with limited mobility, featuring adjustable controls and seating configurations to accommodate varying user needs.
This device is supplied as a reusable, non-sterile medical product, intended for use in clinical, home, or community settings. It is classified as Class II under FDA regulations and is authorised under FDA 510K and MDR. The wheelchair may include multiple FEI numbers (e.g., 3014522447) and is regulated under 21 CFR 890.3860, with no third-party involvement in distribution. Storage and maintenance should follow manufacturer guidelines to ensure safe and effective operation.
Frequently asked questions
What settings can the e-fix E35/E36 wheelchair be used in, and how is it supplied?
The e-fix E35/E36 is designed for use in clinical, home, or community settings to assist individuals with limited mobility. It is supplied as a reusable, non-sterile medical device, meaning it is intended for repeated use by multiple patients after proper cleaning and maintenance. The wheelchair’s adjustable controls and seating configurations allow it to accommodate a variety of user needs.
Is the e-fix E35/E36 available in different sizes or models, and how do I determine the right fit?
The e-fix E35/E36 comes in two primary models, E35 and E36, which likely differ in specific features or configurations to better suit individual user requirements. While the exact size variations aren’t detailed here, the wheelchair is designed with adjustable seating and controls to ensure a customizable fit. For precise sizing, consulting the manufacturer’s guidelines or a healthcare professional familiar with the device’s specifications is recommended.
How should I store the e-fix E35/E36 to ensure it remains functional and safe for use?
The e-fix E35/E36 should be stored according to the manufacturer’s instructions provided by Alber GmbH. Since it is a reusable device, proper storage involves keeping it in a clean, dry environment away from direct sunlight or extreme temperatures. Regular maintenance, as outlined by the manufacturer, will also help preserve its functionality and safety for long-term use.
What regulatory pathways does the e-fix E35/E36 follow, and who is responsible for its distribution?
The e-fix E35/E36 is authorized under both FDA 510K and MDR (Medical Device Regulation) pathways, indicating it has undergone regulatory review for safety and effectiveness. It is classified as a Class II device under FDA regulations and is regulated under 21 CFR 890.3860. Distribution of this device is handled directly by Alber GmbH, with no third-party involvement, ensuring compliance with regulatory requirements.
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 | K161241 | Class II | Active |
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Manufacturer
- Manufacturer
- Alber GmbH
Sources (2)
- FDA 510(k) K161241 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026