Skip to content

Company · US

R82 A/S

FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2016. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (0 in 12 months)

4recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
IOR	Wheelchair, Mechanical	4
INM	Chair, With Casters	2
INN	Chair, Adjustable, Mechanical	1
IPL	Wheelchair, Standup	1
ITJ	Walker, Mechanical	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
May 20, 2016	K151492	Kudu R82 A/S, DK	IOR
Apr 12, 2010	K100084	MULTI FRAME WHEELCHAIR R82 A/S	IOR
Aug 7, 2006	K061810	COUGAR WHEELCHAIR R82 A/S	IOR
Mar 26, 2004	K033460	CHEETAH WHEELCHAIR R82 A/S	IOR
Apr 4, 2003	K030882	RABBIT MOBILE STANDING FRAME R82 A/S	IPL

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Dec 8, 2021	R82 A/S R82 by ETAC Push Brace for High-Low Terminated	INN	None listed
Mar 6, 2020	R82 A/S Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830 Terminated	ITJ	None listed
Mar 28, 2019	R82 A/S Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 935136-00, 953211-00, 953221-00, 953222-00, 953225-00, 953226-00, 953231-001, 953232-00, 953236-00 Produ Terminated	INM	None listed
Jun 30, 2017	R82 A/S Heron toilet and bath chair Model 880505-01 & 880505-11 Open, Classified	INM	None listed

Get alerts for these product codes