FDA.reportPublic FDA data

vive

Primary DI
06974665668452
Brand
vive
Company
Yongkang Youha Electric Appliance Co.,Ltd
Model
YHW001-F
Published
2025-10-18
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
K240329000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240329000Electric wheelchair (YHW001-C;YHW001-D;YHW001-E;YHW001-F)Yongkang Youha Electric Appliance Co., Ltd.2024-03-25ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974665668452PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974665668452069746656684526974665668452

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
541069715
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974665669756JuswellYHW001-F2026-01-26
06974665669688ESHINEYHWL0032025-12-26
06974665669374Meo MoveYHWL0022025-12-17
06974665669442Meo MoveYHWL0032025-12-17
06974665669510FRITTONYHW001-F2025-12-17
06974665669060ZygenairYHW001-C2025-12-15
06974665669138ZygenairYHWL0032025-12-15
06974665668902Neo MoveYHW001-E2025-12-13
06974665668834ZYGENAIRYHW001-D2025-11-18
06974665668216SCIANFJ-MYY-0032025-09-10
06974665668384SCIANFJ-MYY-0012025-09-10
06974665660814MolpeiyYHW001-D2025-08-04
06974665662979ZYGENAIRYHWL0022025-05-19
06974665663402ZYGENAIRYHW001-F2025-05-19
06974665662962ZICONYHWL0022025-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
06975028630581NINGBO 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