Winco Mfg., LLC
Medical device manufacturer in Ocala, FL.
1510(k) clearances
0PMA approvals
33recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K110671 | Winco StretchairINK · Traditional | 04/22/2011SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0066-2017 Class II | TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intended use is to…Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications. | 06/29/2016Terminated |
| Z-0065-2017 Class II | TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended use is to…Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications. | 06/29/2016Terminated |
| Z-0064-2017 Class II | TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair.…Non-conforming component caused arms of TMM4 Stretcher chair to no longer meet design specifications. | 06/29/2016Terminated |
| Z-2403-2015 Class II | Winco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2402-2015 Class II | Winco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2401-2015 Class II | Winco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2400-2015 Class II | Winco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2399-2015 Class II | Winco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2398-2015 Class II | Winco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital Recovery…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2397-2015 Class II | Winco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2396-2015 Class II | Winco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2395-2015 Class II | Winco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2394-2015 Class II | Winco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital Recovery…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2393-2015 Class II | Winco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2392-2015 Class II | Winco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Recovery, Home…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-2391-2015 Class II | Winco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing…Shipment of foam for chairs was received classified as Fire Retardant but was in fact standard foam and… | 04/02/2015Terminated |
| Z-1117-2014 Class II | XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down…A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may… | 09/06/2013Terminated |
| Z-1116-2014 Class II | DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in…A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may… | 09/06/2013Terminated |
| Z-1115-2014 Class II | CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered…A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may… | 09/06/2013Terminated |
| Z-1114-2014 Class II | PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3…A supplier manufacturing assembly defect with the right hand recline mechanism. Use of this product may… | 09/06/2013Terminated |
| Z-0780-2013 Class II | Designer Care Cliner 6700/6704/6710 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO…The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire… | 09/24/2012Terminated |
| Z-0779-2013 Class II | Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO…The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire… | 09/24/2012Terminated |
| Z-0778-2013 Class II | PREMIER CARE RECLINER 5570/5574 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST…The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire… | 09/24/2012Terminated |
| Z-0777-2013 Class II | PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST…The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire… | 09/24/2012Terminated |
| Z-0032-2013 Class II | Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474…Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The recall was… | 07/10/2012Terminated |
| Z-0031-2013 Class II | Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No.…Winco Mfg., LLC in Ocala, FL is recalling the Caremor Cliner model numbers 5351 and 5361. The recall was… | 07/10/2012Terminated |
| Z-1461-2012 | NOCTURNAL ELITE CARE CLINER 6980(STD)/6990(X-LG) products are labeled in part:…Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care… | 02/06/2012Terminated |
| Z-1460-2012 | ELITE CARE CLINER 6940(STD)/6950(X-LG) w/ Swing Arm products are labeled in part:…Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care… | 02/06/2012Terminated |
| Z-1459-2012 | ELITE CARE CLINER 6900 (STD)/6910(X-LG) with Swing-Arm products are labeled in part:…Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care… | 02/06/2012Terminated |
| Z-1458-2012 | CARE CLINER 6550 (STD)/6570 (X-LG) with Drop Arm products are labeled in part: "***CARE…Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care… | 02/06/2012Terminated |
| Z-1457-2012 | CARE CLINER 6530 (STD)/6540 (X-LG) products are labeled in part: "***CARE CLINER…Winco Manufacturing LLC is recalling the Care Cliner, XL Care Cliner, Drop Arm Care Cliner, Elite Care… | 02/06/2012Terminated |
| Z-1106-2012 | Premier Care Recliner Model 5570. Brochure: "***Premier Care Recliner…On 10/17/2011 Winco Mfg. LLC, Ocala, FL initiated a recall of The Premier LifeCare Recliner and Premier Care… | 10/17/2011Terminated |
| Z-1105-2012 | Premier LifeCare Recliner 5400. Brochure is labeled in part: "***Premier LifeCare…On 10/17/2011 Winco Mfg. LLC, Ocala, FL initiated a recall of The Premier LifeCare Recliner and Premier Care… | 10/17/2011Terminated |