Electric Wheelchair (Robooter E60) (BBR-E60-01) +7 more models
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K240339 FDA 510(k)
- FDA Product Code
- ITI FDA 510(k)
- Models / Variants
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 E60 Electric Wheelchair (BBR-E60-01 to BBR-E60-08) is a powered mobility device designed for individuals requiring assistance with ambulation. Classified as a Wheelchair, Powered, it provides motorised propulsion to enhance mobility and independence for users with limited mobility.
These wheelchairs are intended for home, clinical, or community use and are supplied as reusable devices. They comply with FDA 510K and MDR regulatory requirements, with each model (BBR-E60-01 through BBR-E60-08) featuring distinct configurations for varying user needs. No MRI safety or sterility specifications are indicated, and storage conditions are manufacturer-dependent.
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 | K240339 | 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) K240339 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026