FDA.reportPublic FDA data

TuffCare

Primary DI
04719876190079
Brand
TuffCare
Company
SHIN-I MEDICAL MANUFACTURING CO., LTD.
Model
M500
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
INBAttachment, Commode, Wheelchair

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INBAttachment, Commode, WheelchairPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719876190079PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719876190079047198761900794719876190079

GMDN Terms#

Term, Definition table
TermDefinition
Basic toilet seatA seat intended to be attached to a toilet bowl or toilet chair to provide conventional position, stability, and/or comfort to a seated occupant while toileting.

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
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
04719876191588TuffCareT70362026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719876190000TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.INB2026-07-08
04719876190017TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.INB2026-07-08
04719876192301TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.INB2026-07-08
00810178887644ViveVIVE HEALTH LLCINB2026-04-27
00810178884476ViveVIVE HEALTH LLCINB2026-02-02
00810178883806Vive VIVE HEALTH LLCINB2026-01-30
00860014905216MultichairNuprodx, Inc.INB2026-01-27
20885380068321CARDINAL HEALTHCardinal Health 200, LLCINB2025-12-29
50885380068322CARDINAL HEALTHCardinal Health 200, LLCINB2025-12-29
00815027012826DALTON COMMODE CHAIRDALTON MEDICAL CORPORATIONINB2025-09-18
00815027012833DALTON COMMODE CHAIRDALTON MEDICAL CORPORATIONINB2025-09-18
00815027012840DALTON TOILET SEATDALTON MEDICAL CORPORATIONINB2025-09-18
06970289035847HetaidaHetaida Technology Co., LtdINB2025-05-12
16970289035844HetaidaHetaida Technology Co., LtdINB2025-05-12
00194346231423Parent's ChoiceWAL-MART STORES, INC.INB2024-10-29
10194346231420Parent's ChoiceWAL-MART STORES, INC.INB2024-10-29
06976203345221GilogaZhongshan Jiale Rehabilitation Medical Equipment Co., LtdINB2024-07-01
06970289035649HetaidaHetaida Technology Co., LtdINB2024-03-14
16970289035646HetaidaHetaida Technology Co., LtdINB2024-03-14
00810113574219ViveVIVE HEALTH LLCINB2024-01-05
00041298370093HealthSmartD-M-S HOLDINGS, INC.INB2023-07-24
10041298370090HealthSmartD-M-S HOLDINGS, INC.INB2023-07-24
00822383008325DriveDrive Devilbiss HealthcareINB2022-02-01
50822383008320DriveDrive Devilbiss HealthcareINB2022-02-01
M3682195A41LUMEX GF HEALTH PRODUCTS, INC.INB2021-07-14
M3682215B21LUMEX GF HEALTH PRODUCTS, INC.INB2021-07-14
M3682195A40LUMEX GF HEALTH PRODUCTS, INC.INB2021-07-14
M3682215B20LUMEX GF HEALTH PRODUCTS, INC.INB2021-07-14
M368603904A1LUMEX GF HEALTH PRODUCTS, INC.INB2021-07-14
M36890761752J1Everest & JenningsGF HEALTH PRODUCTS, INC.INB2020-12-09