Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1422399

FEI Number

1000143830

Entity Name

TR GROUP, INC.

City/State/Country

Rockford, IL, US

Establishment Address

1643 N Alpine Rd, Ste 104-803, Rockford, IL 61107, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

TR Group, Inc. (Owner Number: 9004783)

Owner / Operator Contact Address

130 North Madison Street, Rockford, IL 61107, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

TR0647500 TR Classic Tilt Table Bure Rise & Go Bure Manual Walking Table Hygiene Chair Basic Bure Electric Walking Table AMFIBI XL Bure XL TR900HCWA, TR1700 TR900H, TR900HC, TR900HCW ,COMFORTLINE IB 4007 Armsling IB 4005 IceBand Knee IB 4008 IceBand Foot/Ankle IB 4006U IceBand Shoulder IB 4010 IceBand Coolerbag TS5000 TS6000 TR9664 TR9651, TR9654, TR9655 Adam Walker TR9663, TR9662 TR9661, Volaris Walker 0699900

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRZ	Device, Patient Transfer, Powered	General Hospital	Class 2	880.6775	1998-01-28
INM	Chair, With Casters	Physical Medicine	Class 1	890.3100	2013-10-31
KTC	Bath, Sitz, Nonpowered	Physical Medicine	Class 1	890.5125	2009-02-11
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2011-03-30
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	2019-07-19
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	1998-01-28
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	1997-08-15

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TR Group, 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
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

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
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1422399. Last updated year: 2026. Please use registration number 1422399 when referencing this establishment in official correspondence.