Data / Medical devices / United States / Champion MFG, INC.

Champion MFG, INC.: FDA-registered device maker in Ocala, FL, United States, 2 510(k) clearances

Name: Champion MFG, INC. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Champion MFG, INC. is registered with the FDA (registration 1027229) in Ocala, FL, United States. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 11, 2016. 9 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1027229
Address: 5516 SW 1st Ln, Ocala, FL, United States, 34474
Owner or operator: Champion Mfg, Inc. (10055089)
Roles: Manufacturer
First device listed: June 5, 2017
Registered through: 2026
Brand names listed: 54 Series, 56 Series, 58 Series, 59 Series, 85 Series, 86 Series, 89 Series, Ascent (65 Series), Ascent II (67 Series),, 54P Series, 56P Series, 58P Series, 59P Series, 85P Series, 86P Series, 89P Series, Ascent (65P Series), Alo Straight Back (61 Series), Alo Straight Back (61P Series), Alo Wing Back (63 Series), Alo Wing Back (63P Series), Alo XL Straight Back (62 Series), Alo XL Straight Back (62P series) and more

Devices it lists

Device	Product code	Class	Role	Source
Chair And Table, Medical	KMN	1	Manufacturer	accessdata.fda.gov
Chair, Adjustable, Mechanical	INN	1	Manufacturer	accessdata.fda.gov
Chair, Blood Donor	FML	1	Manufacturer	accessdata.fda.gov
Chair, Geriatric	FRJ	1	Manufacturer	accessdata.fda.gov
Chair, Surgical, Ac-Powered	GBB	1	Manufacturer	accessdata.fda.gov
Device, Transfer, Patient, Manual	FMR	1	Manufacturer	accessdata.fda.gov
Stretcher, Wheeled, Powered	INK	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 11, 2016	K152056	Winco Model S550 Stretchair	INK	Substantially Equivalent	Winco Manufacturing, LLC	accessdata.fda.gov
April 22, 2011	K110671	WINCO STRETCHAIR	INK	Substantially Equivalent	Winco Mfg., LLC	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
June 29, 2016	74922	Class II	Terminated	TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery	Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications.	accessdata.fda.gov
April 2, 2015	71496	Class II	Terminated	Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, Rehabilitation, Geriatric Home Use, Retirement facilities)	Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and would not meet Fire Retardant standards.	accessdata.fda.gov
November 14, 2014	69671	Class II	Terminated	Powered stretcher chair used during facial and eye surgeries. One chair per package.	The firm is finding that the stretcher chair controllers are moving the chairs involuntarily.	accessdata.fda.gov
September 6, 2013	67377	Class II	Terminated	PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar, Fully upholstered, OPTIONAL Heat or Heat & Massage, OPTIONAL LiquiCell. The products are a multi position recliners wit	A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may result in the loss of functionality of the three (3) position lock bar when in a reclined position.	accessdata.fda.gov
September 24, 2012	63651	Class II	Terminated	PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012 A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dial	The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states.	accessdata.fda.gov
July 10, 2012	63085	Class II	Terminated	Caremor Cliner"*Manufactured By WincoOcala, FL 34474 www.wincomfg.comModel No. 536 Serial No. 536A-101475" Literature: "Caremor Cliner 5351/5361WincoISO 9001-2008 Certified*Our most comfortable and	Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The recall was initiated due to a report that a back frame did not "snap" onto a chair frame properly.	accessdata.fda.gov
February 6, 2012	61457	Not yet classified	Terminated	CARE CLINER 6530 (STD)/6540 (X-LG) products are labeled in part: "*CARE CLINER 6530/6540 (w/NYLON CASTERS)WincoISO 9001-2008 CertifiedOutstanding Value and Quality in Our Standard Care Cliner**Lower price doe	Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care Cliner, and XL Elite Care Cliner chairs with nylon casters distributed between 04/01/2009 and 08/31/2009. Certain 5" nylon casters shipped with the chairs may be defective. There is a potential of the caster's axle working itself out of the assembly under u	accessdata.fda.gov
October 17, 2011	61049	Not yet classified	Terminated	Premier LifeCare Recliner 5400. Brochure is labeled in part: "*Premier LifeCare Recliner 5400WincoISO 9001 2008 CertifiedKey FeaturesUrethane armrestsFully upholsteredMultiple side-table Options*3-p	On 10/17/2011 Winco Mfg. LLC, Ocala, FL initiated a recall of The Premier LifeCare Recliner and Premier Care Recliner Models 5400 and 5570 distributed between January 4, 2011 and October 12, 2011. The Position Lock Pin(s) could potentially fail if exposed to excessive force when the chair is in the Locked Recline position. This failure will result in an inop	accessdata.fda.gov
September 7, 2010	56844	Not yet classified	Terminated	Recalled chairs include the following: 2008 Model Numbers: 653N - Care Cliner, 654N - XL Care Cliner, 655N - Drop Arm Care Cliner, 657N - XL Drop Arm Care Cliner, 690N - Elite Care Cliner, 691N - XL Elite Care Cliner, 69	Winco Mfg., LLC, Ocala, Florida is recalling their Care Cliner. Due to malfunctioning axles which become lose from the caster assembly. This chair is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion. Recalled chairs include the following: Care Cline	accessdata.fda.gov

Compare with other makers

Updated April 11, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.