Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007369190

FEI Number

3007369190

Entity Name

ULTRARAY GROUP INC.

City/State/Country

Oakville Ontario, CA

Establishment Address

760 Pacific Road Unit 3, Oakville Ontario L6L6M5, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Ultraray Group Inc. (Owner Number: 10053207)

Owner / Operator Contact Address

760 Pacific Road Unit 3, Oakville, CA-ON L6L6M5, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SHIELDED POUCH IBIOM - ERGO XR UltraRay UltraRay IBIOM5002 Ultraray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2017-03-01
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2018-03-23
IWO	Apron, Protective	Radiology	Class 1	892.6500	2016-11-10
IWW	Shield, Vial	Radiology	Class 1	892.6500	2016-11-10
LGX	Table, Examination, Medical, Powered	General, Plastic Surgery	Class 1	878.4960	2019-01-29
IWQ	Curtain, Protective, Radiographic	Radiology	Class 1	892.6500	2016-11-10

Official Correspondent

Jon Dunski

US Agent Details

FDAIMPORTS.COM LLC Email: registration@fdaimports.com Phone: (410) 2202800

Related Public Records

Same Entity

Ultraray Group Inc.

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-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 WincoOcala, FL 34474 www.wincomfg.comModel No. 536 Serial No. 536A-101475" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase 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'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair
Z-0032-2013	Winco Mfg., LLC	1	Caremor Cliner is labeled in part: "*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 535 Serial No. 535A-104522" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 CertifiedOur most comfortable and versatile reclinerEase 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'SInfinite positioning backPadded armrests w/arm guardWebbed elastic suspension back and seatRemovable side panelsContinuous seat & legrest cushion5351 w/tray5361 w/out tray1.800.237.33775516 SW 1st LaneOcala, Florida 34474www.wincomfg.comProudly Made in the USA*" Patient recliner chair

Similar Registrations

Registration Number	Establishment Name	Location
3000174892	CANADIAN SCIENTIFIC PRODUCTS LTD. DBA CSP MEDICAL	London Ontario, CA
3029900933	LEMER PAX AMERICA	Montreal Quebec, CA
3043535425	K-ONE MEDITECH SDN. BHD.	Sekinchan Selangor, MY
3005257704	BEIJING KELIDA MEDICAL EQUIPMENT DEVELOPING CO., LTD	Beijing City, CN
3016948452	QINHUANGDAO TAIZHI MEDICAL TECHNOLOGY CO., LTD	Qinhuangdao Hebei, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007369190. Last updated year: 2026. Please use registration number 3007369190 when referencing this establishment in official correspondence.