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510(k) Data Aggregation
K Number
K241159Device Name
Handbike Batec Electric
Manufacturer
Date Cleared
2025-03-07
(315 days)
Product Code
Regulation Number
890.3860Why did this record match?
Applicant Name (Manufacturer) :
Batec Mobility, S.L.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Batec is not intended for specific clinical use, but as a support to the mobility of active manual wheelchairs' users. It is designed to add auxiliary power to the manual wheelchair, increasing the mobility for the wheelchair's user. Therefore, bearing in mind the operating precautions described in this document, there is no need for professional, technical or aptitude requirements to operate or use a Batec device.
Batec devices are intended as add-on devices for wheelchairs, thus the intended user is a person with motor disability who needs of the wheelchair support for movement.
Device Description
The Handbike Batec Electric is a handcycle mechanism that adapts to a manual wheelchair, forming a three-wheeled chair, allowing the user to move with the help of an electric motor located in the front wheel, optimizing the user's capabilities and increasing their autonomy.
Handbike Batec Electric aims to convert a manual wheelchair into an electrically propelled tricycle that allows the disabled collective to make larger and more complex movements and routes that can be made only with the manual wheelchair, increasing their independence and autonomy in daily life by performing recreational and sporting activities.
The operation of the Handbike Batec Electric is the same in all models, changing only the wheel size, maximum speed, and equipment. First the handbike must be coupled to the wheelchair. Once the two parts are attached, we will have a set consisting of three wheelchair seat, the transmission and traction on the front wheel. To operate the handbike, the transmission of the handbike must be operated by pedaling with the controls or by pressing the accelerator. In this way we will drive the front wheel with the manufactured product.
The device has two independent mechanical brakes (right and a parking brake. In addition. there is an automatic speed-limiting motor brake managed by software, which prevents exceeding 120% of the speed limit setting in each mode.
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