FDA.reportPublic FDA data

Batec

Primary DI
08436557351364
Brand
Batec
Company
BATEC MOBILITY SL.
Model
BATEC MINI 2 PLUS TETRA - GRAFITO 15 KM/H
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.
Published
2026-07-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITIWheelchair, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241159000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241159000Handbike Batec ElectricBatec Mobility, S.L.2025-03-07ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08436557351364PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436557351364084365573513648436557351364

GMDN Terms#

Term, Definition table
TermDefinition
Wheelchair electric-motor-driven propulsion systemAn assembly of devices added/retrofitted to a manual wheelchair (occupant or attendant driven) to provide the occupant with an electrical-powered drive mechanism, including the energy source (batteries) to achieve this. The steering, control, and brake systems will typically be included. This retrofitted accessory may alter the wheel configuration of the wheelchair in order to provide the powered propulsion (e.g., from a conventional four-wheeled to a tricycle configuration or additional propulsion wheels at the rear of the wheelchair).

Contacts#

Phone, Email table
PhoneEmail
+0034 663625842jclapes@batec-mobility.com

Regulatory Flags#

DUNS number
512714700
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436557351272BatecBATEC MINI 2 PLUS - GRAFITO 6 KM/H2026-07-29
08436557351289BatecBATEC MINI 2 PLUS TETRA - GRAFITO 6 KM/H2026-07-29
08436557351296BatecBATEC MINI 2 PLUS HEMI DCH - GRAFITO 6 KM/H2026-07-29
08436557351302BatecBATEC MINI 2 PLUS HEMI IZQ - GRAFITO 6 KM/H2026-07-29
08436557351319BatecBATEC MINI 2 PLUS - GRAFITO 10 KM/H2026-07-29
08436557351326BatecBATEC MINI 2 PLUS TETRA - GRAFITO 10 KM/H2026-07-29
08436557351333BatecBATEC MINI 2 PLUS HEMI DCH - GRAFITO 10 KM/H2026-07-29
08436557351340BatecBATEC MINI 2 PLUS HEMI IZQ - GRAFITO 10 KM/H2026-07-29
08436557351357BatecBATEC MINI 2 PLUS - GRAFITO 15 KM/H2026-07-29
08436557351371BatecBATEC MINI 2 PLUS HEMI DCH - GRAFITO 15 KM/H2026-07-29
08436557351388BatecBATEC MINI 2 PLUS HEMI IZQ - GRAFITO 15 KM/H2026-07-29
08436557351432BatecBATEC ELECTRIC 2 PLUS - GRAFITO 6 KM/H2026-07-29
08436557351449BatecBATEC ELECTRIC 2 PLUS TETRA - GRAFITO 6 KM/H2026-07-29
08436557351456BatecBATEC ELECTRIC 2 PLUS HEMI IZQ - GRAFITO 6 KM/H2026-07-29
08436557351463BatecBATEC ELECTRIC 2 PLUS HEMI DCH - GRAFITO 6 KM/H2026-07-29
08436557351470BatecBATEC ELECTRIC 2 PLUS- GRAFITO 10 KM/H2026-07-29
08436557351487BatecBATEC ELECTRIC 2 PLUS TETRA - GRAFITO 10 KM/H2026-07-29
08436557351494BatecBATEC ELECTRIC 2 PLUS HEMI DCH - GRAFITO 10 KM/H2026-07-29
08436557351500BatecBATEC ELECTRIC 2 PLUS HEMI IZQ - GRAFITO 10 KM/H2026-07-29
08436557351517BatecBATEC ELECTRIC 2 PLUS - GRAFITO 15 KM/H2026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08436557351272BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351289BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351296BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351302BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351319BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351326BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351333BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351340BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351357BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351371BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351388BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351432BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351449BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351456BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351463BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351470BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351487BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351494BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351500BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351517BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351524BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351531BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351548BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351593BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351609BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351616BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351623BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351630BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351647BatecBATEC MOBILITY SL.ITI2026-07-29
08436557351654BatecBATEC MOBILITY SL.ITI2026-07-29