Handbike Batec Electric
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241159 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 Handbike Batec Electric is a Powered Wheelchair designed for individuals requiring manual or electric propulsion. It is classified as a Class II medical device and is intended for use by patients needing enhanced mobility through upper-limb-driven or electric motor assistance, supporting physical rehabilitation and independent movement in various environments.
This device is supplied as a reusable, non-sterile mobility aid, intended for use in clinical, home, or community settings. It complies with FDA 510K clearance and MDR requirements, with regulatory classification under 890.3860 and OpenFDA device code ITI. Multiple model variants are listed under the Physical Medicine specialty, reflecting its application in therapeutic and assistive mobility contexts.
Frequently asked questions
What environments is the Handbike Batec Electric designed for use in and how does this affect its suitability for different users?
The Handbike Batec Electric is intended for use in clinical, home, and community settings, making it versatile for patients requiring enhanced mobility. Its design supports both manual and electric propulsion, catering to users who need upper-limb-driven assistance or motorized movement. This versatility ensures it can be used in rehabilitation centers, private homes, or public spaces, accommodating a range of mobility needs across different environments.
Is the Handbike Batec Electric reusable or single-use, and what does this mean for maintenance and cost over time?
The Handbike Batec Electric is explicitly supplied as a reusable device, meaning it is not intended for single-use disposal. This design choice implies that users or facilities will need to follow manufacturer guidelines for cleaning, maintenance, and inspection to ensure safe and prolonged use. While this reduces upfront costs, it requires ongoing investment in upkeep, which may be a consideration for long-term budgeting in clinical or home settings.
How does the Handbike Batec Electric differ from standard powered wheelchairs, and what specific features might appeal to clinicians or users?
Unlike standard powered wheelchairs, the Handbike Batec Electric emphasizes upper-limb-driven propulsion in addition to electric motor assistance, making it particularly suited for users who can operate it manually but may benefit from battery-powered support. This dual functionality can aid in physical rehabilitation by engaging upper-body strength while providing mobility independence. Clinicians may appreciate its classification under *Physical Medicine*, reflecting its role in therapeutic mobility and assistive care.
What regulatory pathways has the Handbike Batec Electric followed, and how does this impact its availability or approval status?
The Handbike Batec Electric has undergone FDA 510K clearance and MDR (Medical Device Regulation) compliance, confirming its regulatory approval in both the U.S. and EU markets. These pathways ensure it meets safety and performance standards for powered wheelchairs under classification 890.3860 and OpenFDA device code ITI. While this does not imply current market availability (as approval ≠ immediate distribution), it confirms the device has met stringent review criteria for its intended use in mobility assistance.
Are there multiple model variants of the Handbike Batec Electric, and if so, how might this affect customization for different users?
Yes, the Handbike Batec Electric includes multiple model variants, as indicated by the extensive list of FEI numbers under OpenFDA. These variants likely cater to different user needs—such as weight capacity, seating configurations, or propulsion adjustments—allowing for greater customization. Clinicians or buyers should consult the manufacturer’s specifications for each variant to select the most appropriate model based on the user’s physical requirements and mobility goals.
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 | K241159 | Class II | Active |
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Manufacturer
- Manufacturer
- Batec Mobility, S.L.
Sources (2)
- FDA 510(k) K241159 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026