Direct Healthcare Group Sverige AB

FDA Device Registration & Listing · Kista Stockholm, SE · Registration 3009481053

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
3009481053
FEI Number
3009481053
Entity Name
Direct Healthcare Group Sverige AB
City/State/Country
Kista Stockholm, SE
Establishment Address
Torshamnsgatan 35, Kista Stockholm 164 40, SE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Direct Healthcare Group Sverige AB (Owner Number: 10041581)
Owner / Operator Contact Address
Torshamnsgatan 35, KISTA, SE-AB 16440, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Handicare Handicare Handicare Handicare Handicare

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
INN Chair, Adjustable, Mechanical Physical Medicine Class 1 890.3100 2014-12-16
IKX Aid, Transfer Physical Medicine Class 1 890.5050 2013-12-11
FSA Lift, Patient, Non-Ac-Powered General Hospital Class 1 880.5510 2012-08-08
INM Chair, With Casters Physical Medicine Class 1 890.3100 2014-12-16
ITJ Walker, Mechanical Physical Medicine Class 1 890.3825 2012-12-21

Official Correspondent

Elisabet Lindberg

US Agent Details

Miriam Walls Business: XFDA, INC Email: mwalls@xfda.com Phone: (703) 9195372

Related Public Records

Same Entity

Direct Healthcare Group Sverige AB
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3009107702 Direct Healthcare Group Sverige AB Reftele Jonkoping, SE

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2018 Handicare AB Maskinvagen 1
Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
Z-0013-2018 Handicare Usa Inc 1
PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
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 3009481053. Last updated year: 2026. Please use registration number 3009481053 when referencing this establishment in official correspondence.
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