FDA.reportPublic FDA data

TuffCare

Primary DI
04719876191977
Brand
TuffCare
Company
SHIN-I MEDICAL MANUFACTURING CO., LTD.
Model
NQ200S
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
IPSCane

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPSCanePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719876191977PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719876191977047198761919774719876191977

GMDN Terms#

Term, Definition table
TermDefinition
Walking aid handgripA device designed to help a person using a walking aid to grasp the walking aid (e.g., a walking stick, cane, crutch, walking frame or rollator) securely. Included are adjustable grips, grips with antislip material and grips of special material such as foam. This is a reusable device.

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
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
04719876191540TuffCareP4602026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719876192189TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.IPS2026-07-08
04719876192196TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.IPS2026-07-08
00199536930230BluelineTransparent Supply Solutions Ltd.IPS2026-05-15
00023601017925CAREX HEALTH BRANDSDrive Devilbiss HealthcareIPS2024-09-09
00023601015877CAREX HEALTH BRANDSDrive Devilbiss HealthcareIPS2024-02-22
00057475247348BIOS LivingThermor LtdIPS2023-09-15
00057475247355BIOS LivingThermor LtdIPS2023-09-15
00057475247683BIOS LivingThermor LtdIPS2023-09-15
00057475247751BIOS LivingThermor LtdIPS2023-09-15
00057475247768BIOS LivingThermor LtdIPS2023-09-15
00057475247775BIOS LivingThermor LtdIPS2023-09-15
00057475560164BIOS LivingThermor LtdIPS2023-09-15
00057475560171BIOS LivingThermor LtdIPS2023-09-15
00057475560188BIOS LivingThermor LtdIPS2023-09-15
00057475560225BIOS LivingThermor LtdIPS2023-09-15
00057475247782BIOS LivingThermor LtdIPS2023-03-31
00057475247799BIOS LivingThermor LtdIPS2023-03-31
00057475247805BIOS LivingThermor LtdIPS2023-03-31
00057475247812BIOS LivingThermor LtdIPS2023-03-31
00057475247829BIOS LivingThermor LtdIPS2023-03-31
00057475247836BIOS LivingThermor LtdIPS2023-03-31
00057475247843BIOS LivingThermor LtdIPS2023-03-31
00057475247850BIOS LivingThermor LtdIPS2023-03-31
00057475247867BIOS LivingThermor LtdIPS2023-03-31
00057475247874BIOS LivingThermor LtdIPS2023-03-31
00057475560058BIOS LivingThermor LtdIPS2023-03-31
00057475560119BIOS LivingThermor LtdIPS2023-03-31
00057475560157BIOS LivingThermor LtdIPS2023-03-31
00023601007117CAREX HEALTH BRANDSDrive Devilbiss HealthcareIPS2023-03-15
00023601007179CAREX HEALTH BRANDSDrive Devilbiss HealthcareIPS2023-03-15