Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1027229

FEI Number

1027229

Entity Name

Champion MFG, INC.

City/State/Country

Ocala, FL, US

Establishment Address

5516 SW 1st Ln, Ocala, FL 34474, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Champion Mfg, Inc. (Owner Number: 10055089)

Owner / Operator Contact Address

5516 SW 1st Ln, Ocala, FL 34474, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Blood Drawing Chair XL Padded Blood Drawing Chair Designer Blood Drawing Chair Padded Blood Drawing Chair S550 Stretchair Care Cliner Elite Comfort Recliner Home Care-Cliner XL Convalescent Recliner Convalescent Recliner Premier Lifecare Recliner Elite Care Cliner Drop Arm Convalescent Recliner Inverness 24 Hour Treatment Recliner Designer Care Cliner Lifecare Recliner Premier Care Cliner Stretchair MC675CL Stretchair S750 Stretchair S675 Recovery Alo Straight Back Power (61PL) Augustine 5001 Ascent II (67P Series), Ascent II XL (68P Series), Ascent XL (66P Series) Recovery Alo Wing Back Power (63PL) 54P Series, 56P Series, 58P Series, 59P Series, 85P Series, 86P Series, 89P Series, Ascent (65P Series) Recovery Alo Wing Back XL Power (64PL Alo XL Straight Back (62P series) Recovery Alo Straight Back XL Manual (620L) Alo Wing Back (63P Series) Recovery Alo Straight Back XL Power (62PL) Recovery Alo Straight Back Manual (610L) Vero Recovery Alo Wing Back Manual (630L) Alo Straight Back (61P Series) Alo XL Wing Back (64P Series) Recovery Alo Wing Back XL Manual (640L) Unity Treatment (310 Series); Unity Treatment Wide (31X Series) Unity Clinical (310 Series); Unity Clinical Wide (31X Series) S400 TMM5 chair TMM 4 PLUS chair TMM5 PLUS chair TMM 3 chair TMM4 chair T3, T4, T5

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FML	Chair, Blood Donor	General Hospital	Class 1	880.6140	2021-12-16
INK	Stretcher, Wheeled, Powered	Physical Medicine	Class 2	890.3690	2021-12-16
FRJ	Chair, Geriatric	General Hospital	Class 1	880.6140	2021-12-16
INK	Stretcher, Wheeled, Powered	Physical Medicine	Class 2	890.3690	2021-12-16
INN	Chair, Adjustable, Mechanical	Physical Medicine	Class 1	890.3100	2021-12-16
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2021-12-16
GBB	Chair, Surgical, Ac-Powered	General, Plastic Surgery	Class 1	878.4960	2017-06-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Champion Mfg, 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-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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1027229. Last updated year: 2026. Please use registration number 1027229 when referencing this establishment in official correspondence.