FDA.reportPublic FDA data

TuffCare

Primary DI
04719876191540
Brand
TuffCare
Company
SHIN-I MEDICAL MANUFACTURING CO., LTD.
Model
P460
Published
2026-07-08
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
FNGLift, Patient, Ac-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FNGLift, Patient, Ac-PoweredGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719876191540PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719876191540047198761915404719876191540

GMDN Terms#

Term, Definition table
TermDefinition
Stand-up mobile patient lifting system, electrically-poweredAn electrically-powered, mobile assembly of devices designed to enable one person to lift an incapacitated patient or a person with a disability from a sitting position into a standing position and then move them from one place to another by physically pushing it with minimal effort with the occupant held secured in the standing position. Also known as a stand-up hoist or standing hoist, it typically consists of a support base on wheels with lifting mechanism, a footrest (footplate), knee/leg supports, a sling/harness, an electrical motor and batteries. It allows secure standing of a patient for toileting, dressing, and transfer.

Regulatory Flags#

DUNS number
656289451
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
true
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
04719876192011TuffCareALX885T2026-07-09
04719876192295TuffCare9972026-07-09
04719876190000TuffCareS9002026-07-08
04719876190017TuffCareS9702026-07-08
04719876190048TuffCareALM842T2026-07-08
04719876190055TuffCareT80362026-07-08
04719876190079TuffCareM5002026-07-08
04719876190215TuffCareALM8312026-07-08
04719876190253TuffCareW500BW2026-07-08
04719876190277TuffCareT40002026-07-08
04719876190383TuffCareP10002026-07-08
04719876190482TuffCareALM831T42026-07-08
04719876190499TuffCareALM842T42026-07-08
04719876190512TuffCareP2702026-07-08
04719876190574TuffCareT52482026-07-08
04719876190581TuffCareT52542026-07-08
04719876190598TuffCareT52602026-07-08
04719876190932TuffCareT80422026-07-08
04719876191519TuffCareP4652026-07-08
04719876191588TuffCareT70362026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719876190383TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNG2026-07-08
04719876190512TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNG2026-07-08
04719876191519TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNG2026-07-08
04719876191618TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNG2026-07-08
04719876191670TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNG2026-07-08
04719876192233TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.FNG2026-07-08
06975960550565noneZhejiang Mateside Medical Devices Technology Co., LtdFNG2026-01-15
00860014621864ValmaxSupply Line MedicalFNG2025-12-22
06975960550558noneZhejiang Mateside Medical Devices Technology Co., LtdFNG2025-09-29
06975960550510VOCICZhejiang Mateside Medical Devices Technology Co., LtdFNG2025-06-04
06975960550527VOCICZhejiang Mateside Medical Devices Technology Co., LtdFNG2025-05-19
06975960551395VOCICZhejiang Mateside Medical Devices Technology Co., LtdFNG2025-04-30
00810178880522ViveVIVE HEALTH LLCFNG2025-04-04
00810178880706ViveVIVE HEALTH LLCFNG2025-04-04
10810178880529ViveVIVE HEALTH LLCFNG2025-04-04
10810178880703ViveVIVE HEALTH LLCFNG2025-04-04
06975960551357maidesiteZhejiang Mateside Medical Devices Technology Co., LtdFNG2025-01-16
06977918410099AireMedJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-12-03
06977918410037SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-11-18
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06977918410082SterexJIANGMEN ELITE MEDICAL EQUIPMENT LTDFNG2024-11-18
05060405748520GBUK LtdGBUK GROUP LIMITEDFNG2024-11-08
05060405747554GBUK LtdGBUK GROUP LIMITEDFNG2024-11-07
00860004936824EasyBoost 400Seneca Devices, Inc.FNG2024-10-17
00860004936831EasyBoostSeneca Devices, Inc.FNG2024-07-31
00860004936855EasyBoostSeneca Devices, Inc.FNG2024-07-09
05060405747837BananaGBUK GROUP LIMITEDFNG2024-01-22