Handicare USA, Inc.

FDA Device Registration & Listing · Maryland Heights, MO, US · Registration 3007802293

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
3007802293
FEI Number
3007802293
Entity Name
Handicare USA, Inc.
City/State/Country
Maryland Heights, MO, US
Establishment Address
10888 Metro Ct., Maryland Heights, MO 63043, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Handicare USA, Inc. (Owner Number: 10029966)
Owner / Operator Contact Address
10888 Metro Ct., Maryland Heights, MO 63043, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Handicare Distributed Product Handicare Ceiling Lifts Handicare Distributed Product Handicare Distributed Product Handicare Lifts and Slings Handicare Distributed Product Handicare Distributed Product

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FPO Stretcher, Wheeled General Hospital Class 2 880.6910 2018-05-14
FSA Lift, Patient, Non-Ac-Powered General Hospital Class 1 880.5510 2009-07-22
INN Chair, Adjustable, Mechanical Physical Medicine Class 1 890.3100 2017-03-09
INM Chair, With Casters Physical Medicine Class 1 890.3100 2017-02-28
FMR Device, Transfer, Patient, Manual General Hospital Class 1 880.6785 2017-03-09
ITJ Walker, Mechanical Physical Medicine Class 1 890.3825 2017-03-09
ILS Adaptor, Hygiene Physical Medicine Class 1 890.5050 2017-03-09

Official Correspondent

Lauren Stover

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Handicare USA, Inc.
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
K830425 Maddak, Inc. TOILET SEAT RAISED 1983-05-09

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2018 Handicare Usa Inc 1
PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered
Z-0023-05 Stryker Medical 2
Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.
Z-0014-2018 Handicare AB Maskinvagen 1
Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007802293. Last updated year: 2026. Please use registration number 3007802293 when referencing this establishment in official correspondence.
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