FDA.reportPublic FDA data

TuffCare

Primary DI
04719876190253
Brand
TuffCare
Company
SHIN-I MEDICAL MANUFACTURING CO., LTD.
Model
W500BW
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
ITJWalker, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITJWalker, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719876190253PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719876190253047198761902534719876190253

GMDN Terms#

Term, Definition table
TermDefinition
Basic walking frame, foldableA mobility aid in the form of a waist-high, foldable framework with handgrips and four, rigid, non-wheeled legs designed to provide a stable support to a person with a disability, a geriatric or an infirm person when standing or ambulating; it may also be used during rehabilitation. It is typically constructed of lightweight metal, plastic, and rubber materials and surrounds the front and flanks of the user. The user holds the handgrips and slightly lifts the device to reposition it in front of them for each forward step. The device is foldable for storage and transportation.

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
true
Serial number
false
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
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
04719876191540TuffCareP4602026-07-08
04719876191588TuffCareT70362026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977176610248BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610255BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610262BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610279BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610286BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610293BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610309BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610316BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610323BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610330BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610347BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610354BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610361BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610378BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610385BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610392BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610408BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610415BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610422BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610439BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610446BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610453BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610460BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610477BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610484BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610491BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610507BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610514BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610521BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25
06977176610538BRADACAREBradacare (XiaMen) Health Technology Co.,LTDITJ2026-08-25