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
06972077023142CostcareXIAMEN ATLANTIS MFC CO.,LTDFNG2026-09-24
06972077023159CostcareXIAMEN ATLANTIS MFC CO.,LTDFNG2026-09-24
06972077023166CostcareXIAMEN ATLANTIS MFC CO.,LTDFNG2026-09-24
06972077024002CostcareXIAMEN ATLANTIS MFC CO.,LTDFNG2026-09-24
06972077024750CostcareXIAMEN ATLANTIS MFC CO.,LTDFNG2026-09-24
06972077024767CostcareXIAMEN ATLANTIS MFC CO.,LTDFNG2026-09-24
06972077024774EvermedXIAMEN ATLANTIS MFC CO.,LTDFNG2026-09-24
06972077024781EvermedXIAMEN ATLANTIS MFC CO.,LTDFNG2026-09-24
06972077024798CostcareXIAMEN ATLANTIS MFC CO.,LTDFNG2026-09-24
06972077024804EvermedXIAMEN ATLANTIS MFC CO.,LTDFNG2026-09-24
06972077024811EvermedXIAMEN ATLANTIS MFC CO.,LTDFNG2026-09-24
06972077024828CostcareXIAMEN ATLANTIS MFC CO.,LTDFNG2026-09-24
06972077024880CostcareXIAMEN ATLANTIS MFC CO.,LTDFNG2026-09-24
06975084500712AtlantisXIAMEN ATLANTIS MFC CO.,LTDFNG2026-09-24
06975084500729AtlantisXIAMEN ATLANTIS MFC CO.,LTDFNG2026-09-24
06975084500736AtlantisXIAMEN ATLANTIS MFC CO.,LTDFNG2026-09-24
06975084500743AtlantisXIAMEN ATLANTIS MFC CO.,LTDFNG2026-09-24
06972077025399MeditecXIAMEN ATLANTIS MFC CO.,LTDFNG2026-09-19
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