FDA.reportPublic FDA data

LUMEX

Primary DI
M368FR601ULH4271
Brand
LUMEX
Company
GF HEALTH PRODUCTS, INC.
Model
FR601ULH427
Device description
RECL DLX CL CR PVT ARM EXT LEG HM BL RIDGE
Published
2024-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
INMChair, With Casters

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INMChair, With CastersPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M368FR601ULH4271PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Reclining chairA manually-operated, general-purpose device designed to support a patient in a seated position; it includes a back rest that reclines for patient comfort. The chair is intended to be used in a variety of settings including recovery from minor procedures, during convalescence, while donating blood, or while receiving chemotherapy. It may have a height-adjustable mechanism and have attached armrests, footrests, and/or legrests.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
7703684700cs@grahamfield.com

Regulatory Flags#

DUNS number
132016168
Device count
1
Premarket exempt
true
Serial number
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
06973717276829VerpalFoshan Dahao Medical Technology Co., Ltd.INM2026-06-06
00840117408739ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408746ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408753ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408760ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408777ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408784ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408791ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00840117408807ConvaidCONVAID PRODUCTS, INC.INM2026-04-10
00841447116479Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116486Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116493Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116509Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116516Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00841447116523Easy Glide Transport Chair for InvacareINVACARE CORPORATIONINM2026-04-10
00193489028754GUARDIANMEDLINE INDUSTRIES, INC.INM2026-04-02
00884389150835MEDLINEMEDLINE INDUSTRIES, INC.INM2026-02-26
40884389150802MEDLINEMEDLINE INDUSTRIES, INC.INM2026-02-26
40884389150819MEDLINEMEDLINE INDUSTRIES, INC.INM2026-02-26
00840117408340ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408357ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408364ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408371ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408388ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408395ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408401ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408418ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408425ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408432ConvaidCONVAID PRODUCTS, INC.INM2026-02-05
00840117408449ConvaidCONVAID PRODUCTS, INC.INM2026-02-05