Robooter E40 Electric Wheelchair (Model BBR-E40-01)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K231868 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 Robooter E40 Electric Wheelchair (Model BBR-E40-01) is a powered mobility device designed for individuals requiring assistance with ambulation. Classified as a Wheelchair, Powered under regulatory nomenclature, it provides motorised propulsion to enhance mobility and independence for users with limited mobility.
This device is intended for use in clinical and home settings, supplied as a reusable medical product. It has been authorised under FDA 510K and MDR regulatory pathways, with a classification as Class II. The wheelchair is not single-use and does not require sterile conditions. No MRI safety information is specified in the provided data.
Frequently asked questions
What settings can the Robooter E40 Electric Wheelchair be used in, and how is it supplied for use?
The Robooter E40 Electric Wheelchair is designed for use in both clinical environments like hospitals and home settings for individuals who need assistance with mobility. It is supplied as a reusable medical product, meaning it is intended for repeated use by multiple patients or users, provided proper cleaning and maintenance protocols are followed.
Is the Robooter E40 Electric Wheelchair single-use or reusable, and does it require sterile conditions?
The Robooter E40 is explicitly classified as a reusable medical device. It does not require sterile conditions for use, which makes it suitable for long-term deployment in both clinical and home settings without the need for single-use disposal.
What regulatory pathways has the Robooter E40 Electric Wheelchair followed, and what does that mean for its use?
The Robooter E40 has been authorized through the FDA 510K pathway and the EU’s Medical Device Regulation (MDR). This means it has undergone regulatory review to demonstrate substantial equivalence to a legally marketed device in the U.S. and compliance with EU safety, performance, and quality requirements, ensuring its suitability for clinical and home use as a powered mobility aid.
Are there any specific size or model variations available for the Robooter E40 Electric Wheelchair?
The provided data only specifies the model name BBR-E40-01 for the Robooter E40 Electric Wheelchair. While the data does not detail specific size variations, the device is classified under the regulatory category of *Wheelchair, Powered*, which typically includes adjustable features for user comfort and mobility needs. For precise sizing options, consulting the manufacturer’s technical specifications or sales documentation is recommended.
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 | K231868 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shanghai Bangbang Robotics Co., Ltd.
Sources (2)
- FDA 510(k) K231868 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026