FDA.reportPublic FDA data

INVACARE CORP. DBA INVACARE AMERICA

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
15311863002889431INVACARE CORP. DBA INVACARE AMERICA1Y2026-01-0138850 Taylor Parkway N Ridgeville OH US 44035

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
28201012699977K935398TRACER SERIES MANUAL WHEELCHAIRSIOR1994-03-01
28202060779823K920105SCALAMOBILING1992-08-06
28201495736819K881951RIDE-LITE 9000 SERIES WHEELCHAIRIOR1988-05-19
28201222754739K232198Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF)IOR2023-09-15
28201124844798K202379Invacare AVIVA Storm RX Power ChairITI2021-03-19
28201233812291K192216Invacare AVIVA FX Power Wheelchair, Model: IFX-20MPITI2020-01-02
28201617876535K182946Invacare TDX SP2-HD with Captain's SeatITI2018-12-11
28201322398777K181090Invacare® Solara® 3G and Solara® 3G Spree Manual WheelchairsIOR2018-11-14
28201332722351K170507Invacare® TDX® SP2 Power Wheelchair; TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low MaxxITI2017-07-12
28201220507214K162621Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual WheelchairIOR2017-04-17
28201057734440K141783TDX SP2 POWER WHEECHAIRITI2015-01-09
28202005851274K112816ZHENJIANG ASURE MECHANICAL WHEELCHAIRIOR2012-04-18
28201535504949K060582INVACARE TOPAZ BARIATRIC MANUAL WHEELCHAIRIOR2006-03-16
28201125640561K052468YK9000 SERIES MANUAL WHEELCHAIRIOR2005-10-05
28201792628948K023589STORM TDX POWER WHEELCHAIRITI2002-11-19
28201408894512K020386INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02CAW2002-07-02
28201778257775K002170MODEL 9000 PEDIATRIC WHEELCHAIRIOR2000-08-04
28201368536907
28201659176264
28201849265481
28201021024461
28201043790833
28201071572292
28201082583895
28201090660877
28201104657279
28201108468141
28201130538136
28201194686160
28201198779685
28201274435750
28201342906802
28201416731868
28201455157530
28201481515454
28201495566954
28201543647416
28201581094041
28201664406503
28201760255981
28201775877782
28201813577409
28201820387508
28201895230765
28201950011336
28201950334082
28201955091752
28201964245641
28201999647837

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IOR92023-09-15
ITI62021-03-19
CAW12002-07-02
ING11992-08-06