FDA.reportPublic FDA data

Lumex

Primary DI
M3686484R21
Brand
Lumex
Company
GF HEALTH PRODUCTS, INC.
Model
6484R-2
Catalog number
6484R-2
Device description
Raised Toliet Seat Cushion
Published
2020-09-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
M3686484R22PackageHIBCC2In Commercial Distribution
M3686484R21PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Toilet cushionA soft pillow or pad designed to provide support, comfort, and assistance to the user while sitting on a toilet or commode seat. The device is designed to evenly distribute body weight, absorb shock, and adjust height for the user who has difficulty bending to or rising from a low position.

Contacts#

Phone, Email table
PhoneEmail
770-368-4700cs@grahamfield.com

Regulatory Flags#

DUNS number
132016168
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M368EPC500ST1HAUSTEDEPC500ST2026-04-09
M368EPC500STMB1HAUSTEDEPC500ST-MB2026-04-09
M3681097001GRAHAM FIELD109-7002026-02-20
M36812731Grafco127312732020-10-01
M36812751Grafco127512752020-10-01
M3684001GF1GRAFCO4001GF4001GF2020-04-01
M3684002GF1GRAFCO4002GF4002GF2020-04-01
M3682362X1GRAHAM FIELD2362X2026-02-20
M3681097002GRAHAM FIELD109-7002026-02-20
M3682338A1GRAHAM FIELD2338A 2026-02-20
M3682338X1GRAHAM FIELD2338X2026-02-20
M36823452A1GRAHAM FIELD2345-2A2026-02-20
M36823452C1GRAHAM FIELD2345-2C 2026-02-20
M36823452X1GRAHAM FIELD2345-2X2026-02-20
M36823481A1GRAHAM FIELD2348-1A 2026-02-20
M36823552N1GRAHAM FIELD2355-2N 2026-02-20
M36823552X1GRAHAM FIELD2355-2X 2026-02-20
M36823562A1GRAHAM FIELD2356-2A 2026-02-20
M36823562C1GRAHAM FIELD2356-2C 2026-02-20
M36823562N1GRAHAM FIELD2356-2N 2026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
M3689B007700J1Everest & JenningsGF HEALTH PRODUCTS, INC.INB2020-12-09
M3689B045035J1Everest & JenningsGF HEALTH PRODUCTS, INC.INB2020-12-09
M3689B232870J1Everest & JenningsGF HEALTH PRODUCTS, INC.INB2020-12-09