Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615386

FEI Number

3003769112

Entity Name

Handicare Canada, Ltd.

City/State/Country

Concord Ontario, CA

Establishment Address

81 Romina Drive, Concord Ontario L4K 3V4, CA

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Handicare Canada Ltd. (Owner Number: 9033644)

Owner / Operator Contact Address

10888 Metro Court, Maryland Heights, MO 63043, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Handicare Ceiling Lifts Handicare Distributed Product

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	1998-04-22
FPO	Stretcher, Wheeled	General Hospital	Class 2	880.6910	2020-07-13

Official Correspondent

Lauren Stover

US Agent Details

Lauren Stover Business: Handicare Email: lauren.stover@handicare.com Phone: (314) 2198668

Related Public Records

Same Entity

Handicare Canada Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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-0014-2018	Handicare AB Maskinvagen	1	Carina Mobile Lifts, Models: a) Carina350EM, REF 6060011 b) Carina350EML, REF 60600012 c) Carina350EE, REF 60600009
Z-0023-05	Stryker Medical	2	Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615386. Last updated year: 2026. Please use registration number 9615386 when referencing this establishment in official correspondence.