Winco Mfg., LLC

FDA Regulatory Profile

Summary

Total Recalls
26
510(k) Clearances
1
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0066-2017Class IITransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intended use is to provide theJune 29, 2016
Z-0065-2017Class IITransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended use is to provide the caJune 29, 2016
Z-0064-2017Class IITransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair. Intended use isJune 29, 2016
Z-2395-2015Class IIWinco Drop Arm Care Cliner Standard - with Nylon Casters Oncology, Dialysis, Hospital Recovery, HomApril 2, 2015
Z-2397-2015Class IIWinco Drop Arm Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, HomeApril 2, 2015
Z-2393-2015Class IIWinco Care Cliner X-Large - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home DialysisApril 2, 2015
Z-2391-2015Class IIWinco XL Convalescent Recliner - with Steel Casters Long term patient recliner (Nursing, RehabilitaApril 2, 2015
Z-2392-2015Class IIWinco Care Cliner Standart - Steel Casters Oncology, Dialysis, Hospital Recovery, Home Dialysis UseApril 2, 2015
Z-2402-2015Class IIWinco Inverness 24-Hour Treatment Recliner - with Nylon Casters Lay Flat Clinical Patient Recliner April 2, 2015
Z-2400-2015Class IIWinco Elite Care Cliner w/Swing Away Arms Standard - with Nylon Casters Oncology, Dialysis, HospitaApril 2, 2015
Z-2394-2015Class IIWinco Care Cliner X-Large - with Steel Casters Oncology, Dialysis, Hospital Recovery, Home DialysisApril 2, 2015
Z-2396-2015Class IIWinco Drop Arm Care Cliner Standard - with Steel Casters Oncology, Dialysis, Hospital Recovery, HomApril 2, 2015
Z-2398-2015Class IIWinco Designer Care Cliner - with Nylon Casters Oncology, Dialysis, Hospital Recovery, Home DialysiApril 2, 2015
Z-2401-2015Class IIWinco Elite Care Cliner w/Swing Away Arms X-Large - with Nylon Casters Oncology, Dialysis, HospitalApril 2, 2015
Z-2403-2015Class IIWinco Nocturnal Elite Care Cliner - with Nylon Casters Lay Flat Clinical Patient Recliner w/ TrendeApril 2, 2015
Z-2399-2015Class IIWinco Designer Care Cliner w/Swing Arms - with Nylon Casters Oncology, Dialysis, Hospital Recovery,April 2, 2015
Z-1114-2014Class IIPREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar,September 6, 2013
Z-1117-2014Class IIXL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, RemoSeptember 6, 2013
Z-1115-2014Class IICONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, RecessSeptember 6, 2013
Z-1116-2014Class IIDROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, PaSeptember 6, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K110671WINCO STRETCHAIRApril 22, 2011