R82 a/S

GEDVED Midtjylland, DK

R82 A/S appears in FDA device records in GEDVED Midtjylland, DK. FDA records list one 510(k) clearance, no PMA records and one registered establishment. As of 2026-09-10, FDA records show 4 recalls for this company, and at least one establishment registration is current.

510(k) clearances: 1
PMA records: 0
Recall records: 4
Registered establishments: 1

510(k) clearance history

FDA records hold 1 510(k) clearance for R82 a/S in 2016.

Clearances by year, as a table

510(k) clearance decisions for R82 a/S, by decision year
Year	Clearances
2016	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K151492	Kudu	IOR	Substantially Equivalent	2016-05-20

Registered establishments

FDA registered establishments for R82 a/S, with the product codes listed at each
Registration	FEI	Establishment	Address	Registration expires	Product codes listed
3001657382	3001657382	R82 A/S	PARALLELVEJ 3, GEDVED Midtjylland DK-8751 DK	2026	ILS INM INN INQ INW IOR ITJ KNO LBE

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
Z-0569-2022	R82 by ETAC Push Brace for High-Low	The chrome surface of the push brace can crack during use, potentially cutting the user.	Class II	2021-12-08	Terminated
Z-1858-2020	Chest Support for R82 Mustang, Model Numbers: 861810, 861820, 861830; and Rabbit Up, Model Numbers: 869810, 869820, 869830	The plastic plug on the chest support for Mustang and Rabbit/Rabbit Up can come loose without use of a tool.	Class II	2020-03-06	Terminated
Z-1315-2019	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 Product Usage: Activity chair (wheelchair)	Firm received feedback form the market regarding breakage of the plastic joint which connects the back to the seat.	Class II	2019-03-28	Terminated
Z-0441-2019	Heron toilet and bath chair Model 880505-01 & 880505-11	Replacement campaign on all units that have a gas spring head in aluminum.	Class II	2017-06-30	Open, Classified

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets R82 a/S edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

Claim this page

Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain