FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506083952
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
8000-2340
Catalog number
8000-2340
Device description
MOTOR GEAR WHEEL - LARGE
Published
2025-07-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRKChair, Examination And Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRKChair, Examination And TreatmentGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506083952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506083952001985060839521985060839520198506083952

GMDN Terms#

Term, Definition table
TermDefinition
Examination/treatment table, line-poweredA mobile, mains electricity (AC-powered) motorized table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework or a large pedestal with a flat table top surface which consists of some articulated sections that can be adjusted into a raised position. The height of the table top surface will also be power-adjusted. It is typically used in examination rooms, endoscopy facilities, electrophysiology (EP) laboratories, or outpatient departments for minor interventions.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198506090967ELMED INCORPORATED37120-3537120-352026-05-26
00198506090974ELMED INCORPORATEDSTE36101ESTE36101E2026-05-26
00198506090981ELMED INCORPORATEDSTE3641ESTE3641E2026-05-26
00198506090998ELMED INCORPORATEDSTE245013STE2450132026-05-26
00198506091001ELMED INCORPORATEDSTE245014STE2450142026-05-26
00198506091018ELMED INCORPORATEDSTE245015STE2450152026-05-26
00198506091025ELMED INCORPORATEDSTE245016STE2450162026-05-26
00198506091032ELMED INCORPORATEDSTE245017STE2450172026-05-26
00198506091049ELMED INCORPORATEDSTE245018STE2450182026-05-26
00198506091056ELMED INCORPORATEDSTE245019STE2450192026-05-26
00198506091063ELMED INCORPORATEDSTE245020STE2450202026-05-26
00198506091070ELMED INCORPORATEDSTE245021STE2450212026-05-26
00198506091087ELMED INCORPORATEDSTE245022STE2450222026-05-26
00198506091100ELMED INCORPORATEDSTE322924ISTE322924I2026-05-26
00198506091117ELMED INCORPORATEDSTE322923ISTE322923I2026-05-26
00198506091124ELMED INCORPORATEDSTE3211221ESTE3211221E2026-05-26
00198506090899ELMED INCORPORATEDSM13600-10SM13600-102026-05-19
00198506090905ELMED INCORPORATED33370-2733370-272026-05-19
00198506090912ELMED INCORPORATED35-6291435-629142026-05-19
00198506090929ELMED INCORPORATED33761-2133761-212026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08500190351415Maxi S4000 Exam Chair, Power Base/Recline, Arms, Art HR, WhiteBoyd Industries, Inc.FRK2025-12-26
00728564010005Versa Exam TableThe Brewer Company LLCFRK2025-11-10
00728564015000Blood Drawing ChairThe Brewer Company LLCFRK2025-11-10
00728564020103Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564020301Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564020400Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564021100Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564021308Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564021407Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564022107Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564022305Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564022404Element Treatment TableThe Brewer Company LLCFRK2025-11-10
00728564050001Access Exam TableThe Brewer Company LLCFRK2025-11-10
00728564050018Access Exam TableThe Brewer Company LLCFRK2025-11-10
00840456201015JMUJMU DENTAL, INCFRK2025-07-15
00840456201022JMUJMU DENTAL, INCFRK2025-07-15
00840456201039JMUJMU DENTAL, INCFRK2025-07-15
00840456201046JMUJMU DENTAL, INCFRK2025-07-15
00840456202906JMUJMU DENTAL, INCFRK2025-07-15
00840456202913JMUJMU DENTAL, INCFRK2025-07-15
00840456202920JMUJMU DENTAL, INCFRK2025-07-15
00840456202937JMUJMU DENTAL, INCFRK2025-07-15
06973134772133silverfoxSilverfox Corporation LimitedFRK2025-07-09
06973134774113silverfoxSilverfox Corporation LimitedFRK2025-07-09
D974BSI29111BritedentBright Supply, Inc.FRK2025-03-11
D974BSI29112BritedentBright Supply, Inc.FRK2025-03-11
00198506075179ELMED INCORPORATEDELMED INCORPORATEDFRK2025-02-17
00842180190122ELMEDELMED INCORPORATEDFRK2024-04-09
00842180147768ELMEDELMED INCORPORATEDFRK2024-03-06
06973134774052silverfoxSilverfox Corporation LimitedFRK2023-12-15