FDA.reportPublic FDA data

Champion

Primary DI
00850001188166
Brand
Champion
Company
Champion Manufacturing Inc.
Model
Passage Medical Recliner
Catalog number
Passage
Device description
Passage, Medical Recliner, Standard Capacity, Fixed 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
00850001188166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850001188166008500011881668500011881660850001188166

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
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
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