FDA.reportPublic FDA data

Hi-Fortune

Primary DI
06973852599326
Brand
Hi-Fortune
Company
Kunshan Hi-Fortune Health Products Co.,Ltd
Model
HY320
Published
2026-07-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
FRZDevice, Patient Transfer, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRZDevice, Patient Transfer, PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06973852599326PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06973852599326069738525993266973852599326

GMDN Terms#

Term, Definition table
TermDefinition
Mobile patient lifting system, electrically-poweredAn electrically-powered, mobile assembly of devices designed to enable one person to lift and move an incapacitated patient or a person with a disability safely and with minimal physical effort. Also known as a patient hoist, it typically consists of a support base on wheels with a motorized lifting mechanism, mast, boom/lifting arm(s), swivel bar, a patient holding device (e.g., a sling, holder or a frame). It is typically used to lift and move the occupant in a sitting or semi-sitting position over short distances within the treatment facility, e.g., from a bed to a bathroom.

Regulatory Flags#

DUNS number
548310008
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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
00199874887180Prism AirPrism Pacific Industries LLCFRZ2026-07-10
00816299013191HoverSling Repositioning SheetHovertech InternationalFRZ2026-05-12
00816299013214HoverMatt SPU LinkHovertech InternationalFRZ2026-05-12
00816299013238HoverMatt SPU LinkHovertech InternationalFRZ2026-05-12
00816299013252HoverMatt SPU LinkHovertech InternationalFRZ2026-05-12
00816299013276HoverSling Repositioning SheetHovertech InternationalFRZ2026-05-12
00816299012965HoverMatt PROS AirHovertech InternationalFRZ2026-02-27
00816299012989HoverMatt PROS AirHovertech InternationalFRZ2026-02-27
00816299013030HoverMatt PROS Air SlingHovertech InternationalFRZ2026-02-27
00816299012958HoverMatt PROS AirHovertech InternationalFRZ2026-02-27
00816299012972HoverMatt PROS AirHovertech InternationalFRZ2026-02-27
00816299012996HoverMatt PROS AirHovertech InternationalFRZ2026-02-27
00816299013047HoverMatt PROS Air SlingHovertech InternationalFRZ2026-02-27
00841962120456Alta for HexaPODQfixFRZ2026-01-14
00816299013016HoverMatt PROS Air SlingHovertech InternationalFRZ2026-01-12
B237ZEPACR110Zephyr Patient Positioning and Transfer SystemDiacor, Inc.FRZ2025-12-23
00841962120388Lumen AirShuttleQfixFRZ2025-12-02
00841962120395Symphony Locating Bar, PH StyleQfixFRZ2025-12-02
B237ZCPAST100Zephyr Patient Positioning and Transfer SystemDiacor, Inc.FRZ2025-11-13
10841962119457Symphony Locating Bar, Prodigy2™QfixFRZ2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixFRZ2025-10-23
10193489121117MEDLINEMEDLINE INDUSTRIES, INC.FRZ2025-10-15
10193489121124MEDLINEMEDLINE INDUSTRIES, INC.FRZ2025-10-15
B237ZEPAUB800Zephyr Patient Positioning and Transfer SystemDiacor, Inc.FRZ2025-09-26
00841962120340Edge Guide SystemQfixFRZ2025-09-11
10885380203114Sustainable TechnologiesCardinal Health 200, LLCFRZ2025-09-10
10885380203121Sustainable TechnologiesCardinal Health 200, LLCFRZ2025-09-10
10885380203138Sustainable TechnologiesCardinal Health 200, LLCFRZ2025-09-10
10885380203145Sustainable TechnologiesCardinal Health 200, LLCFRZ2025-09-10
00816299012644HoverMatt PROS-AIRHovertech InternationalFRZ2025-09-10