R82 A/S

FDA Device Registration & Listing · GEDVED Midtjylland, DK · Registration 3001657382

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3001657382
FEI Number
3001657382
Entity Name
R82 A/S
City/State/Country
GEDVED Midtjylland, DK
Establishment Address
PARALLELVEJ 3, GEDVED Midtjylland DK-8751, DK
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
R82 A/S (Owner Number: 9034750)
Owner / Operator Contact Address
Parallelvej 3, --, Gedved, DK-82 DK-8751, DK
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Kudu Crocodile Pony Mustang Flamingo Swan Heron Wombat Living Chilla Stingray frame Swan Curo Flamingo High-Low Flamingo Curo Penguin Orca Caribou Gazelle PS Toucan Meerkat Rabbit Up Addax Meerkat Caribou Multi Frame Swan Stingray Frame Orca Heron Gazelle PS Cricket Penguin Pony Flamingo High-Low Swan Curo Kudu Strong Base Manatee Wombat Living Crocodile Toucan Stingray Seat Mustang Rabbit Up High-Low:Xo Flamingo X:panda Chilla Scallop X:Panda Shape High-Low:xo Stingray seat x:panda Manatee Strong Base x:panda shape Multi frame Caribou

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LBE Stroller, Adaptive Physical Medicine Class 1 890.3850 2018-08-06
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2018-08-06
ITJ Walker, Mechanical Physical Medicine Class 1 890.3825 2002-03-09
INM Chair, With Casters Physical Medicine Class 1 890.3100 2014-08-12
ILS Adaptor, Hygiene Physical Medicine Class 1 890.5050 2014-08-12
INW Table, Mechanical Physical Medicine Class 1 890.3750 2002-03-09
KNO Accessories, Wheelchair Physical Medicine Class 1 890.3910 2009-01-09
INN Chair, Adjustable, Mechanical Physical Medicine Class 1 890.3100 2002-03-09
IOR Wheelchair, Mechanical Physical Medicine Class 1 890.3850 2018-08-06
INQ Table, Powered Physical Medicine Class 1 890.3760 2009-01-11

Official Correspondent

Stefan Ryom

US Agent Details

Gio Espinosa Business: Director QA/RA Email: gespinosa@kimobility.com Phone: (715) 5707860

Related Public Records

Same Entity

R82 A/S
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K935211 Brookefield Hunter, Inc. WALK N CHAIR 1994-02-02
K832685 Health America WHEELCHAIR-VARIOUS MODELS 1983-09-20
K830425 Maddak, Inc. TOILET SEAT RAISED 1983-05-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0011-2015 Nemschoff Chairs, Inc. 909 N 8th St 2218 Julson Ct Sheboygan WI 53081-4056 1
Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, and Serenity IIS: 792-12. Designed to provide patient comfort during patient treatment sessions. The chair may include a manual control reclining mechanism. Customer configurable models are also available. The Serenity III Exam 791-12E was discontinued 11/1/2010.
Z-0031-2013 Winco Mfg., LLC 1
Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No. 536A-101475***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***" Patient recliner chair
Z-0032-2013 Winco Mfg., LLC 1
Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 535 Serial No. 535A-104522***" Literature: "***Caremor Cliner 5351/5361***Winco***ISO 9001-2008 Certified***Our most comfortable and versatile recliner***Ease of operation, outstanding durability, and exceptional value have made this one of our bestselling recliners. The Caremor Cliner provides patient comfort and support as well as user friendly features.***KEY FEATURE'S***Infinite positioning back***Padded armrests w/arm guard***Webbed elastic suspension back and seat***Removable side panels**Continuous seat & legrest cushion***5351 w/tray***5361 w/out tray***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 34474***www.wincomfg.com***Proudly Made in the USA***" Patient recliner chair

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3001657382. Last updated year: 2026. Please use registration number 3001657382 when referencing this establishment in official correspondence.
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