FDA.reportPublic FDA data

Hi-Fortune

Primary DI
06973852590064
Brand
Hi-Fortune
Company
Kunshan Hi-Fortune Health Products Co.,Ltd
Model
HR-111-02
Device description
Weight: 7.8kg, L570mm*W390mm*H985mm
Published
2021-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
KNLBoard, Scooter, Prone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNLBoard, Scooter, PronePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973852590064PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973852590064069738525900646973852590064

GMDN Terms#

Term, Definition table
TermDefinition
Assistive scooter, foot-propelledA mobility device with two main wheels attached to a footboard (sometimes with stabilizing wheels at the rear) and a steering handle directly connected to the front wheel, that is designed to be operated by a person with a disability who propels the device by pushing on the ground with one foot while standing on the footboard with the other. This device is used to enhance the user's ability for self-transportation in the local environment and/or to promote the user's physical/recreational activities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
548310008
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration 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
06973852592068Hi-FortuneHP358EA2025-03-21
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
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
00858101008131Mini Mobile StanderRIFTON EQUIPMENTKNL2022-09-16
00858101008148Small Mobile StanderRIFTON EQUIPMENTKNL2022-09-16
00858101008155Medium Mobile StanderRIFTON EQUIPMENTKNL2022-09-16
00858101008162Large Mobile StanderRIFTON EQUIPMENTKNL2022-09-16
00858101008100Medium Prone StanderRIFTON EQUIPMENTKNL2022-09-16
00858101008117Large Prone StanderRIFTON EQUIPMENTKNL2022-09-16
00858101008094Small Prone StanderRIFTON EQUIPMENTKNL2022-09-16