FDA.reportPublic FDA data

Batec

Primary DI
08436557350572
Brand
Batec
Company
BATEC MOBILITY SL.
Model
BATEC SCRAMBLER 2 STD - GRAFITO 6 KM/H
Catalog number
25.52.029
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
2025-04-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
08436557350572PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08436557350572084365573505728436557350572

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).

Sterilization Methods#

Method table
Method

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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08436557350169BatecBATEC ELECTRIC 2 STD - GRAFITO 15 KM/H25.61.0132025-04-02
08436557350176BatecBATEC ELECTRIC 2 TETRA STD - GRAFITO 15 KM/H25.61.0142025-04-02
08436557350183BatecBATEC ELECTRIC 2 HEMI DER STD - GRAFITO 15 KM/H25.61.0152025-04-02
08436557350190BatecBATEC ELECTRIC 2 HEMI IZQ STD - GRAFITO 15KM/H25.61.0162025-04-02
08436557350206BatecBATEC SCRAMBLER 2 STD - GRAFITO 15 KM/H25.61.0172025-04-02
08436557350213BatecBATEC SCRAMBLER 2 TETRA STD - GRAFITO 15 KM/H25.61.0182025-04-02
08436557350220BatecBATEC SCRAMBLER 2 HEMI DER STD - GRAFITO 15 KM/H25.61.0192025-04-02
08436557350237BatecBATEC SCRAMBLER 2 HEMI IZQ STD - GRAFITO 15 KM/H25.61.0202025-04-02
08436557350282BatecBATEC MINI 2 STD - GRAFITO 15 KM/H25.90.0182025-04-02
08436557350299BatecBATEC MINI 2 HEMI DCH STD - GRAFITO 15 KM/H25.90.0202025-04-02
08436557350305BatecBATEC MINI 2 TETRA STD - GRAFITO 15 KM/H25.90.0192025-04-02
08436557350312BatecBATEC MINI 2 HEMI IZQ STD - GRAFITO 15 KM/H25.90.0212025-04-02
08436557350381BatecBATEC ELECTRIC 2 STD - GRAFITO 6 KM/H25.52.0252025-04-02
08436557350398BatecBATEC ELECTRIC 2 TETRA STD - GRAFITO 6 KM/H25.52.0262025-04-02
08436557350404BatecBATEC ELECTRIC 2 HEMI DCH STD - GRAFITO 6 KM/H25.52.0272025-04-02
08436557350411BatecBATEC ELECTRIC 2 HEMI IZQ STD - GRAFITO 6 KM/H25.52.0282025-04-02
08436557350589BatecBATEC SCRAMBLER 2 TETRA STD - GRAFITO 6 KM/H25.52.0302025-04-02
08436557350596BatecBATEC SCRAMBLER 2 HEMI DCH STD - GRAFITO 6 KM/H25.52.0312025-04-02
08436557350602BatecBATEC SCRAMBLER 2 HEMI IZQ STD - GRAFITO 6 KM/H25.52.0322025-04-02
08436557350619BatecBATEC RAPID 2 STD - GRAFITO 6 KM/H25.52.0332025-04-02

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