FDA.reportPublic FDA data

Champion

Primary DI
00850001188173
Brand
Champion
Company
Champion Manufacturing Inc.
Model
Passage Medical Recliner
Catalog number
Passage
Device description
Passage, Medical Recliner, Standard Capacity, Swing-Away Arm
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
INNChair, Adjustable, Mechanical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850001188173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001188173008500011881738500011881730850001188173

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
8009985018customerservice@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
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
00850001188210Champion59P Series Medical Relax Recliner 59P Series 2023-06-08

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
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
00850001752176Compass Chair Size 2RIFTON EQUIPMENTINN2022-09-16