FDA.reportPublic FDA data

TuffCare

Primary DI
04719876192318
Brand
TuffCare
Company
SHIN-I MEDICAL MANUFACTURING CO., LTD.
Model
397XDB
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
IORWheelchair, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IORWheelchair, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04719876192318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04719876192318047198761923184719876192318

GMDN Terms#

Term, Definition table
TermDefinition
Push-rim manual wheelchair, bariatricA non-powered wheeled personal mobility device with an oversized seat designed to enable a bariatric person without the full capacity to walk to self-mobilize by pushing specially designed rims on the wheels while seated. It is designed with a pair of larger wheels with push-rims attached whereby the occupant propels the device by rotating both wheels; it typically includes rear-fitted handles designed for optional pushing by an attendant. It provides no function outside of wheeled mobilization.

Regulatory Flags#

DUNS number
656289451
Device count
1
DM exempt
true
Premarket exempt
false
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
04719876191540TuffCareP4602026-07-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719876192295TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.IOR2026-07-09
04719876191953TuffCareSHIN-I MEDICAL MANUFACTURING CO., LTD.IOR2026-07-08
00822383037127Silver SportDrive Devilbiss HealthcareIOR2026-06-22
00822383037134Silver SportDrive Devilbiss HealthcareIOR2026-06-22
00822383037141Silver SportDrive Devilbiss HealthcareIOR2026-06-22
00822383037158Cruiser 3 16"Drive Devilbiss HealthcareIOR2026-06-22
00822383037165Cruiser 3 18"Drive Devilbiss HealthcareIOR2026-06-22
00822383037172Cruiser 3 20"Drive Devilbiss HealthcareIOR2026-06-22
06970006394691DAYANG MEDICALGuangdong Dayang Medical Technology Co.,LtdIOR2026-06-10
06975996304019Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304026Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304033Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304040Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
06975996304057Manual wheelchairGuangdong Xiangyuanheng Medical Technology Co., Ltd.IOR2026-05-30
M36867262250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867282250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867302250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867322030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867322050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
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M36867342030R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342050R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342230R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31
M36867342250R1GENDRONGF HEALTH PRODUCTS, INC.IOR2025-10-31