Champion Mfg, Inc.
Ocala, FL, US
Champion MFG, INC. appears in FDA device records in Ocala, FL. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 35 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
3 namesFDA records resolved to Champion Mfg, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Transmotion Medical, Inc.510(k), enforcement report, recall
- Winco Mfg., LLC510(k), enforcement report, recall
- Winco, Inc.recall
510(k) clearance history
FDA records hold 3 510(k) clearances for Champion Mfg, Inc. between 1995 and 2011. The busiest year on record is 1995, with 1. The most recent is 2011, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1995 | 1 |
| 2009 | 1 |
| 2011 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K110671 | WINCO STRETCHAIR | INK | Substantially Equivalent | |
| K091043 | POWER DRIVE CHAIR, MODEL: TMM6 | INK | Substantially Equivalent | |
| K951414 | CHAMPION PHYSIOACOUSTICC RECLINER-TRANSPORTER CHAIR | IRO | Substantially Equivalent for Some Indications |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1027229 | 1027229 | Champion MFG, INC. | 5516 SW 1st Ln, Ocala, FL 34474 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 35| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0066-2017 | TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment. | Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications. | Class II | Terminated | |
| Z-0065-2017 | TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended use is to provide the caregiver a single platform for receiving, transporting within a facility, performing procedures, recovery and discharge of patients in a monitored outpatient environment. | Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications. | Class II | Terminated | |
| Z-0064-2017 | 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 and discharge of patients in a monitored outpatient environment. | Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications. | Class II | Terminated | |
| Z-2403-2015 | Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician 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. | Class II | Terminated | |
| Z-2402-2015 | Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ Trendelenburg (Long Term Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician 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. | Class II | Terminated | |
| Z-2401-2015 | Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician 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. | Class II | Terminated | |
| Z-2400-2015 | Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician 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. | Class II | Terminated | |
| Z-2399-2015 | Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician 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. | Class II | Terminated | |
| Z-2398-2015 | Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician 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. | Class II | Terminated | |
| Z-2397-2015 | Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician 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. | Class II | Terminated | |
| Z-2396-2015 | Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician 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. | Class II | Terminated | |
| Z-2395-2015 | Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician 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. | Class II | Terminated | |
| Z-2394-2015 | Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician 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. | Class II | Terminated | |
| Z-2393-2015 | Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician 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. | Class II | Terminated | |
| Z-2392-2015 | Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis Use, Physician 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. | Class II | Terminated | |
| Z-2391-2015 | 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. | Class II | Terminated | |
| Z-0996-2015 | 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. | Class II | Terminated | |
| Z-1117-2014 | XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Removable side panels, Built-in head-rest. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors. | 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. | Class II | Terminated | |
| Z-1116-2014 | DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Padded push-handle, Three-position lock, Over-lap tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors. | 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. | Class II | Terminated | |
| Z-1115-2014 | CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recessed hand-grips, Webbed suspension seating, Non-porous tray. The products are a multi position recliners with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors. | 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. | Class II | Terminated | |
| Z-1114-2014 | 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 with a steel frame used primarily in long term care or convalescent facilities. The recliners are suitable as general purpose seating for relaxation, reclining, eating, patient transport within the facility, and as a patient room chair for visitors. | 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. | Class II | Terminated | |
| Z-0780-2013 | Designer Care Cliner 6700/6704/6710 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, dialysis, oncology, examination, infusion. | 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. | Class II | Terminated | |
| Z-0779-2013 | Cozy Comfort Premier Recliner 5580 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, dialysis, oncology, examination, infusion. | 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. | Class II | Terminated | |
| Z-0778-2013 | PREMIER CARE RECLINER 5570/5574 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, dialysis, oncology, examination, infusion. | 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. | Class II | Terminated | |
| Z-0777-2013 | 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, dialysis, oncology, examination, infusion. | 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. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain