FDA.reportPublic FDA data

Hi-Fortune

Primary DI
06973852592068
Brand
Hi-Fortune
Company
Kunshan Hi-Fortune Health Products Co.,Ltd
Model
HP358EA
Published
2025-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K211647000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211647000HP358EA Electrically Powered WheelchairKunshan Hi-Fortune Health Products Co., Ltd.2022-01-04ITI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973852592068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973852592068069738525920686973852592068

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
548310008
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06973852590118Hi-FortuneHP3302026-04-29
06973852593034Hi-FortuneHM303D-I2026-04-29
06973852595588Hi-FortuneHP5582025-03-26
06973852599623Hi-FortuneHP2062025-03-26
06973852592006Hi-FortuneHP2002025-03-21
06973852593331Hi-FortuneHP2022025-03-21
06973852593584Hi-FortuneHP358E2025-03-22
06973852590101Adjustable mattressH003, H101, H104, H009, H102, H105, H010, H103, H12023-04-24
06973852594581Hi-FortuneP16H2022-05-24
06973852596035Hi-FortuneHY6032022-05-24
06973852591085Hi-FortuneHY1082022-03-23
06973852590033Hi-FortuneHM303D2021-10-23
06973852590040Hi-FortuneHM03MS2021-10-23
06973852590057Hi-FortuneTLS-2002021-10-23
06973852590064Hi-FortuneHR-111-022021-10-23
06973852590071Hi-FortuneHY2012021-10-23
06973852590088Hi-FortuneHY101-01A2021-10-23
06973852590095Hi-FortuneHY1062021-10-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973175531430MOGOAnhui JBH Medical Apparatus Co., Ltd.ITI2026-05-30
00860015909206VeloxVelox Manufacturing IncITI2026-05-28
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
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