FDA.reportPublic FDA data

NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.

Primary DI
06975028630529
Brand
NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.
Company
Ningbo Youhuan Automation Technology Co., Ltd
Model
artemis pro
Published
2025-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K240638000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240638000Power Wheelchair (YH-E7007)Ningbo Youhuan Automation Technology Co., Ltd.2024-09-16ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975028630529PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975028630529069750286305296975028630529

GMDN Terms#

Term, Definition table
TermDefinition
Electric-motor-driven wheelchair, occupant-controlledAn electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
709462082
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975028630116NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.SHAWK2026-05-21
06975028630581NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.Pathan2026-05-21
06975028630888NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.kano2025-09-01
06975028636576NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.YH-E6012A2025-09-01
06975028645806NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.Nora2025-09-01
06975028636538NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.YH-E70012025-07-31
06975028630741NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.Leopard2025-08-15
06977365711558NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.wildcat2025-08-15
06975028630734NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.wolf2025-04-25
06975028630628NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.artemis2025-02-24
06975028630215YOUHUANYH-E70072025-01-30

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
08436557351364BatecBATEC 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