FDA.reportPublic FDA data

LUMEX

Primary DI
M3687921RA1
Brand
LUMEX
Company
GF HEALTH PRODUCTS, INC.
Model
7921RA
Catalog number
7921RA
Device description
BATH SEAT W/BACK & ARMS RETAIL
Published
2021-08-12
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
INNChair, Adjustable, Mechanical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INNChair, Adjustable, MechanicalPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M3687921RA1PrimaryHIBCC0
M3687921RA0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bath back rest/seatA device designed to support the back, and sometimes buttocks, of a patient (usually an adult) who is bathing in a bath (usually while being attended/assisted) to enable the patient to sit in an upright, and sometimes elevated, position in the bath. The patient is typically disabled, infirm, or undergoing medical treatment and cannot sit normally in a bath. The device may be a back rest only or a seat with an incorporated back rest, typically made of water-resistant or waterproof materials; it may be laid across the rim of the bath or secured to the bath. The device may be used in a hospital, institution, or home.

Contacts#

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

Regulatory Flags#

DUNS number
132016168
Device count
3
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
04034089107745Swifty 3 Reha-Buggy (LB)Thomas Hilfen für Körperbehinderte GmbH & Co. Medico KommanditgesellschaftINN2026-05-26
05715393055838R82R82 A/SINN2026-03-26
05715393078868R82R82 A/SINN2026-03-26
00840456218709JMUJMU DENTAL, INCINN2026-03-09
00840456218716JMUJMU DENTAL, INCINN2026-03-09
00840456218723JMUJMU DENTAL, INCINN2026-03-09
00840456218730JMUJMU DENTAL, INCINN2026-03-09
00840456218747JMUJMU DENTAL, INCINN2026-03-09
00840456218754JMUJMU DENTAL, INCINN2026-03-09
00840456218761JMUJMU DENTAL, INCINN2026-03-09
00840456218778JMUJMU DENTAL, INCINN2026-03-09
06975960550589noneZhejiang Mateside Medical Devices Technology Co., LtdINN2026-01-15
10858921006222ActiveAidALTIMATE MEDICAL INC.INN2026-01-05
00860014545825Peri-Chair LLCPERI-CHAIR, LLCINN2025-10-15
00628758004448RazRaz Design IncINN2025-05-28
00062875800444RazRaz Design IncINN2025-03-11
08055715708316GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708323GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708330GRILLO CHAIRORMESA SRLINN2025-01-31
08055715708347GRILLO CHAIRORMESA SRLINN2025-01-31
10858921006215ActiveAidALTIMATE MEDICAL INC.INN2025-01-09
00628758009009ZwimRaz Design IncINN2024-11-06
05707581000751Shower SeatRopox A/SINN2022-12-08
05707581000768Shower SeatRopox A/SINN2022-12-08
05707581000775Shower SeatRopox A/SINN2022-12-08
05707581000782Shower SeatRopox A/SINN2022-12-08
07320451321794Etac Supply Center ABEtac Supply Center ABINN2022-12-08
07320451321817Etac Supply Center ABEtac Supply Center ABINN2022-12-08
07320451351173Etac Supply Center ABEtac Supply Center ABINN2022-12-08
00850001752169Compass Chair Size 1RIFTON EQUIPMENTINN2022-09-16