FDA.report

Batec

Primary DI
08436557350381
Brand
Batec
Company
BATEC MOBILITY SL.
Model
BATEC ELECTRIC 2 STD - GRAFITO 6 KM/H
Catalog number
25.52.025
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

Related Records

Product Codes

CodeName
ITIWheelchair, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
ITIWheelchair, PoweredPhysical Medicine2

Premarket Submissions

SubmissionSupplement
K241159000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08436557350381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08436557350381084365573503818436557350381

GMDN Terms

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

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 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
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
08436557350572BatecBATEC SCRAMBLER 2 STD - GRAFITO 6 KM/H25.52.0292025-04-02
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06973175531164Ranger SpaceproAnhui JBH Medical Apparatus Co., Ltd.ITI2026-03-21
00810203610940ComfyGOComfyGO, IncITI2026-03-10
06977027830917A NaicinZhejiang Nysin Medical Co.,LtdITI2026-02-27
06977027830924A NaicinZhejiang Nysin Medical Co.,LtdITI2026-02-27
06977027830931A NaicinZhejiang Nysin Medical Co.,LtdITI2026-02-27
G450ARK5500FOLD & GO WheelchairsOnekubed Designs LLCITI2026-02-27
04719873856701KarmaKARMA MOBILITY COMPANY LIMITEDITI2026-02-25
06972665816019Nanjing Kangni Smart Technology Co., Ltd.Nanjing Kangni Smart Technology Co., Ltd.ITI2026-02-11
06977027830900Call of OasisZhejiang Nysin Medical Co.,LtdITI2026-01-29
06974665669756JuswellYongkang Youha Electric Appliance Co.,LtdITI2026-01-26
06979367050017AstrawheelZhejiang Automwheel Tech Co., LtdITI2026-01-23
06974573542035EshineYurob Rehabilitation Medical Co.,LtdITI2026-01-20
00810203610407ComfyGOComfyGO, IncITI2026-01-07
00810203610568ComfyGOComfyGO, IncITI2026-01-07
00810203610827ComfyGOComfyGO, IncITI2026-01-07
06974665669688ESHINEYongkang Youha Electric Appliance Co.,LtdITI2025-12-26
06978949462538Journey Health & LifestyleZhejiang Innuovo Rehabilitation Devices Co., LtdITI2025-12-19
06974665669374Meo MoveYongkang Youha Electric Appliance Co.,LtdITI2025-12-17
06974665669442Meo MoveYongkang Youha Electric Appliance Co.,LtdITI2025-12-17
06974665669510FRITTONYongkang Youha Electric Appliance Co.,LtdITI2025-12-17
06974665669060ZygenairYongkang Youha Electric Appliance Co.,LtdITI2025-12-15
06974665669138ZygenairYongkang Youha Electric Appliance Co.,LtdITI2025-12-15
06974665668902Neo MoveYongkang Youha Electric Appliance Co.,LtdITI2025-12-13
06976680650009Superpi Electric WheelchairSuperpi Robot Co., Ltd.ITI2025-12-08
B247GP306Wheelchair PoweredGOLDEN BROTHERS, INC.ITI2025-12-08
B247GP307Wheelchair PoweredGOLDEN BROTHERS, INC.ITI2025-12-08
06970575220988Travel BuggySUZHOU KD INTELLIGENT DEVICE CO., LTDITI2025-11-25
06974665668834ZYGENAIRYongkang Youha Electric Appliance Co.,LtdITI2025-11-18
06976245015564Power WheelchairZheJiang J&J Mobility Co., LtdITI2025-11-18
00606509100403Jazzy EVO 613 AirPride Mobility Products CorpITI2025-11-14