FDA.reportPublic FDA data

NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.

Primary DI
06975028630581
Brand
NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.
Company
Ningbo Youhuan Automation Technology Co., Ltd
Model
Pathan
Published
2026-05-21
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
06975028630581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975028630581069750286305816975028630581

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).

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
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
06975028630529NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.artemis pro2025-02-24
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
06973134773017sliverfoxSilverfox Corporation LimitedITI2026-05-27
04046727184476e-motion®Alber GmbHITI2026-05-26
04046727184483e-motion®Alber GmbHITI2026-05-26
04046727184490e-motion®Alber GmbHITI2026-05-26
04046727248994e-fix®Alber GmbHITI2026-05-26
04046727250928e-fix®Alber GmbHITI2026-05-26
04046727250935e-fix®Alber GmbHITI2026-05-26
04046727250942e-fix®Alber GmbHITI2026-05-26
04046727250959e-fix®Alber GmbHITI2026-05-26
04046727250966e-fix®Alber GmbHITI2026-05-26
04046727250980e-fix®Alber GmbHITI2026-05-26
04046727250997e-fix®Alber GmbHITI2026-05-26
04046727251000e-fix®Alber GmbHITI2026-05-26
04046727251017e-fix®Alber GmbHITI2026-05-26
04046727251048e-fix®Alber GmbHITI2026-05-26
04046727251055e-fix®Alber GmbHITI2026-05-26
06973717276683Dahao MedicalFoshan Dahao Medical Technology Co., Ltd.ITI2026-05-26
06976245010361Power WheelchairZheJiang J&J Mobility Co., LtdITI2026-05-26
06976245010378Power WheelchairZheJiang J&J Mobility Co., LtdITI2026-05-26
00199874244891AMP plusMethod Mobility, Inc.ITI2026-05-25
00199874251073AMPMethod Mobility, Inc.ITI2026-05-25
00199874773407AMP jsMethod Mobility, Inc.ITI2026-05-25
06973717276690VerpalFoshan Dahao Medical Technology Co., Ltd.ITI2026-05-25
06976245010187Power WheelchairZheJiang J&J Mobility Co., LtdITI2026-05-25
06975028630116NINGBO YOUHUAN AUTOMATION TECHNOLOGY CO., LTD.Ningbo Youhuan Automation Technology Co., LtdITI2026-05-21
06973175531300MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-09
06973175531317MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-09
06973175531324MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-09
06973175531331MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-09
06973175531201MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-04-30