Invacare Corporation

FDA Regulatory Profile

Summary

Total Recalls
37
510(k) Clearances
20
Inspections
34
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-1251-2024Class IIInvacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) GJanuary 22, 2024
Z-2445-2023Class IIDOLOMITE GLOSS ROLLATOR - intended to support during walking and may also serve as a resting seat. June 15, 2023
Z-1369-2022Class IIIInvacare Platinum 5NXG Oxygen Concentrator, Model Numbers P5NXG1, P5NXGC1 (Canada specific model)June 10, 2022
Z-1130-2022Class IIInvacare TDX SP2, Model Nos. TDXSP2 TDXSP2-MCG TDXSP2VMarch 30, 2022
Z-0445-2022Class IIInvacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A aNovember 12, 2021
Z-0447-2022Class IIInvacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRYNovember 12, 2021
Z-0446-2022Class IIInvacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-ANovember 12, 2021
Z-0514-2021Class IIInvacare PerfectO2 V Oxygen Concentrator- intended for patients with respiratory disorders requiringOctober 30, 2020
Z-0549-2019Class IIInvacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a November 16, 2018
Z-2218-2017Class IIAssist Bed Rail - 6632April 25, 2017
Z-1183-2017Class IIBariatric Bed - BARPKG-IVC 1633December 2, 2016
Z-1184-2017Class IIFoot Section - BAR5490IVCDecember 2, 2016
Z-1182-2017Class IIBariatric Bed - BAR600IVCDecember 2, 2016
Z-1185-2017Class IIJunction Box - 1104343 and 1193560December 2, 2016
Z-2365-2016Class IIInvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvacaJune 21, 2016
Z-2364-2016Class IIlnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare June 21, 2016
Z-2399-2016Class IIInvacare¿ Bariatric Bed w/o mattress & rails, Junction Boxes, Product Usage: The Invacare BariaMarch 15, 2016
Z-2402-2016Class IIJunction Boxes, Product Usage: The Invacare Bariatric home care bed is intended to provide a reMarch 15, 2016
Z-2401-2016Class IIInvacare¿ Foot Section for Semi & Full Electric Beds, Junction Boxes, Product Usage: The InvacaMarch 15, 2016
Z-2400-2016Class IIInvacare¿ Bariatric Bed with mattress and rails , Junction Boxes, Product Usage: The Invacare BMarch 15, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K203210Invacare Platinum 5NXG Oxygen ConcentratorApril 12, 2021
K202379Invacare AVIVA Storm RX Power ChairMarch 19, 2021
K200890Invacare Perfecto2V Oxygen ConcentratorAugust 6, 2020
K192216Invacare AVIVA FX Power Wheelchair, Model: IFX-20MPJanuary 2, 2020
K191159Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, August 29, 2019
K182946Invacare TDX SP2-HD with Captain's SeatDecember 11, 2018
K181090Invacare® Solara® 3G and Solara® 3G Spree Manual WheelchairsNovember 14, 2018
K170507Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base foJuly 12, 2017
K162621Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual WheelchairApril 17, 2017
K162692Kuschall K-Series Attract Manual WheelchairDecember 28, 2016
K162696Kuschall Advance Manual WheelchairDecember 28, 2016
K162686Kuschall Champion Manual WheelchairDecember 28, 2016
K160630Invacare Platinum Mobile Oxygen ConcentratorSeptember 27, 2016
K152536MyOn HC Manual WheelchairJanuary 5, 2016
K141783TDX SP2 POWER WHEECHAIRJanuary 9, 2015
K083751INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100May 21, 2009
K073134A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40INovember 16, 2007
K060582INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIRMarch 16, 2006
K042483INVACARE PRO, COMPACT AND PORTABLE DESKTOPJanuary 6, 2005
K041072KUSCHALL CHAMPION, KUSCHALL COMPACT, KUSCHALL ULTRA-LIGHTMay 12, 2004