FDA.reportPublic FDA data

Hi-Fortune

Primary DI
06973852590033
Brand
Hi-Fortune
Company
Kunshan Hi-Fortune Health Products Co.,Ltd
Model
HM303D
Device description
Weight: 10.5kg, L770mm*W325mm*H760mm
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
IMNClimber, Curb, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMNClimber, Curb, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973852590033PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973852590033069738525900336973852590033

GMDN Terms#

Term, Definition table
TermDefinition
All-plastic conventional wheelchairAn all-plastic wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (non-bariatric) and designed to be manually propelled by the occupant while seated in the device or by an attendant. The occupant moves the device by rotating both rear wheels. An attendant moves the device by pushing or pulling handles on the device. It contains no metal parts and may be safely used in magnetic resonance imaging (MRI) environments and security scanners, submersed in water (e.g., swimming pool, balneotherapy), and used in a shower. The device cannot be folded or readily dismantled for transport.

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
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
06973852590040Hi-FortuneKunshan Hi-Fortune Health Products Co.,LtdIMN2021-10-23