Data / Medical devices / Sweden / Permobil AB

Permobil AB: FDA-registered device maker in Sundsvall Vasternorrland, Sweden, 9 510(k) clearances

Name: Permobil AB FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Permobil AB is registered with the FDA (registration 8030931) in Sundsvall Vasternorrland, Sweden. It lists 21 device types. The FDA files 9 510(k) clearances under its listings, the newest dated February 27, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 8030931
FEI number: 3004908349
Address: Klokanvagen 16, Sundsvall Vasternorrland, Sweden, 86341
Owner or operator: PERMOBIL INC (8030931)
Roles: Manufacturer, Specification developer
First device listed: May 17, 2006
Registered through: 2026
Brand names listed: Anti-Tip Device, Armboard, Armrest, Cane and Crutch Holder, Crutch and Cane Holder, Curb Climber, Explorer Mini, Extension Brake and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Wheelchair	KNO	1	Manufacturer, Specification developer	accessdata.fda.gov
Armboard, Wheelchair	IMY	1	Manufacturer	accessdata.fda.gov
Armrest, Wheelchair	IML	1	Manufacturer	accessdata.fda.gov
Attachment, Narrowing, Wheelchair	IMQ	1	Manufacturer	accessdata.fda.gov
Belt, Wheelchair	IQB	1	Manufacturer	accessdata.fda.gov
Board, Lap, Wheelchair	IMX	1	Manufacturer	accessdata.fda.gov
Brake, Extension, Wheelchair	IMW	1	Manufacturer	accessdata.fda.gov
Climber, Curb, Wheelchair	IMN	1	Manufacturer	accessdata.fda.gov
Components, Wheelchair	KNN	1	Manufacturer, Specification developer	accessdata.fda.gov
Cuff, Pusher, Wheelchair	INC	1	Manufacturer	accessdata.fda.gov
Cushion, Wheelchair	IMP	1	Manufacturer	accessdata.fda.gov
Device, Anti-Tip, Wheelchair	IMR	1	Manufacturer	accessdata.fda.gov
Footrest, Wheelchair	IMM	1	Manufacturer	accessdata.fda.gov
Handrim, Wheelchair	IMO	1	Manufacturer	accessdata.fda.gov
Hill Holder, Wheelchair	INA	1	Manufacturer	accessdata.fda.gov
Holder, Crutch And Cane, Wheelchair	IMZ	1	Manufacturer	accessdata.fda.gov
Medical Device Data System	OUG	1	Specification developer	accessdata.fda.gov
Restraint, Wheelchair, Non-Protective	KID	1	Manufacturer	accessdata.fda.gov
Support, Head And Trunk, Wheelchair	IMS	1	Manufacturer	accessdata.fda.gov
Wheelchair, Powered	ITI	2	Specification developer	accessdata.fda.gov
Wheelchair, Standup	IPL	2	Specification developer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 27, 2020	K190682	Explorer Mini	IPL	Substantially Equivalent	Permobil AB	accessdata.fda.gov
October 25, 2019	K191874	F5 Corpus VS	IPL	Substantially Equivalent	Permobil AB	accessdata.fda.gov
March 27, 2015	K143180	F3	ITI	Substantially Equivalent	Permobil AB	accessdata.fda.gov
March 25, 2015	K143014	F5	ITI	Substantially Equivalent	Permobil AB	accessdata.fda.gov
April 17, 2013	K123290	M300 & M400	ITI	Substantially Equivalent	Permobil AB	accessdata.fda.gov
March 3, 2011	K103477	PERMOBIL M300 / M400	ITI	Substantially Equivalent	Permobil AB	accessdata.fda.gov
July 29, 2008	K081964	K450 POWERED WHEELCHAIR	ITI	Substantially Equivalent	Permobil AB	accessdata.fda.gov
August 4, 2004	K041219	ELECTRO	ITI	Substantially Equivalent	Permobil AB	accessdata.fda.gov
April 30, 1997	K960951	PERMOBIL CHAIRMAN L/CS 8	ITI	Substantially Equivalent	Permobil AB	accessdata.fda.gov

Compare with other makers

Updated February 27, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.