FDA.reportPublic FDA data

Champion

Primary DI
00850001188463
Brand
Champion
Company
Champion Manufacturing Inc.
Model
Unity Treatment Recliner Wide 31X Series
Catalog number
3800-000-302
Device description
Unity Treatment Recliner Wide 31X Series
Published
2023-06-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
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
00850001188463PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001188463008500011884638500011884630850001188463

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose stool/chairA seat, usually height-adjustable, intended to be occupied by staff or patients during medical procedures, examinations, or rest; it may include support for the back, arms and feet (footrest/ring). It is not dedicated to a specific clinical specialty, procedure, or location. It may be used in a healthcare facility, office, or in the home.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-998-5018customerservice@championchair.com

Regulatory Flags#

DUNS number
786987859
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850001188005ChampionClassic 547547 2023-06-08
00850001188012ChampionConcord Series ReclinerConcord 2023-06-08
00850001188029Champion54 Series Medical Recliner54 Series2023-06-08
00850001188036Champion56 Series Medical Recliner56 Series2023-06-08
00850001188043Champion58 Series Medical Recliner58 Series2023-06-08
00850001188050Champion59 Series Medical Recliner59 Series2023-06-08
00850001188067ChampionAlo Medical ReclinerAlo2023-06-08
00850001188081ChampionAscent Medical ReclinerAscent2023-06-08
00850001188098ChampionAscent Medical Recliner XLAscent2023-06-08
00850001188104ChampionAscent II Medical Recliner Ascent II2023-06-08
00850001188111ChampionAscent II Medical Recliner XLAscent II XL2023-06-08
00850001188128ChampionContinuum ReclinerContinuum 2023-06-08
00850001188135Champion85 Series Medical Recliner85 Series2023-06-08
00850001188142Champion86 Series Medical Recliner XL86 Series XL2023-06-08
00850001188159Champion89 Series Medical Relax Recliner89 Series2023-06-08
00850001188166ChampionPassage Medical ReclinerPassage2023-06-08
00850001188173ChampionPassage Medical ReclinerPassage2023-06-08
00850001188180Champion54P Series Medical Recliner54P Series2023-06-08
00850001188197Champion56P Series Medical Recliner XL56P Series XL2023-06-08
00850001188203Champion58P Series Medical Relax Recliner XL58P Series XL2023-06-08

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
00198506083952ELMED INCORPORATEDELMED INCORPORATEDFRK2025-07-11
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