510(k) K840627

Device: AMPUTEE WHEELCHAIR
Applicant: POIRIER S.A.
510(k) number: K840627
Product code: IQC
Decision: Substantially Equivalent (SESE)
Decision date: 1984-02-27
Date received: 1984-01-20
Regulation: 890.3880
Classification name: Wheelchair, Special Grade
Medical specialty: Physical Medicine
Review panel: Physical Medicine
Device class: 2
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

3005442882
3009560097

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IQC #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K251570	Hippocampe Marathon and Trail	Vipamat Sarl	2025-06-23
K120302	MECHANICAL WHEELCHAIR	Novaf Andalucia 2007, SL	2012-07-06
K082857	RENEGADE WHEELCHAIR	Alpha One	2009-01-06
K051709	HIPPOCAMPE WHEELCHAIR	Vipamat Technologie	2005-08-15
K895384	CALIFORNIA COMFORT FOUR WHEEL	Jubilee Scooters, Inc.	1989-09-18
K861943	PCI CUSTOM DESIGN SERIES	Poston & Cole Intl.	1986-05-30
K843213	QUALINE WHEELCHAIR PRODUCTS	Contemporary Health Sys	1984-08-24
K842719	STANDARD WHEELCHAIR	Greene International Corp.	1984-07-25
K840234	POIRIER VARIABLE WHEELCHAIR	Poirier S.A.	1984-02-27
K840625	UNION WHEELCHAIR	Poirier S.A.	1984-02-27
K840628	LARGE FRONT WHEELS WHEELCHAIR	Poirier S.A.	1984-02-27
K840630	POIRIER REGLADE WHEELCHAIR	Poirier S.A.	1984-02-27
K840631	ARNAS WHEELCHAIR	Poirier S.A.	1984-02-27
K840632	HEMIPLEGIC WHEELCHAIR	Poirier S.A.	1984-02-27
K840634	OLYMPIC & BASKET WHEELCHAIRS	Poirier S.A.	1984-02-27

Legacy Summary#

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