FDA 510(k) Applications Submitted by Elijah Wreh

FDA 510(k) Number Submission Date Device Name Applicant
K200343 02/11/2020 FusionFrame Ring Lock System GLW Medical Innovation
K200890 04/03/2020 Invacare Perfecto2V Oxygen Concentrator Invacare Corporation
K131132 04/23/2013 PELVIS II IMPLANT SYSTEM Stryker Trauma AG
K141121 04/30/2014 AXSOS 3 TI LOCKING PLATE SYSTEM Stryker Trauma AG
K191159 05/01/2019 Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentra Invacare Corporation
K192216 08/15/2019 Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP Invacare Corporation
K202379 08/20/2020 Invacare AVIVA Storm RX Power Chair Invacare Corporation
K182946 10/23/2018 Invacare TDX SP2-HD with Captain's Seat Invacare Corporation
K203210 10/30/2020 Invacare Platinum 5NXG Oxygen Concentrator Invacare Corporation
K133440 11/12/2013 AXSOS 3 TI LOCKING PLATE SYSTEM LINE EXTENSION Stryker Trauma AG
K140259 02/03/2014 VARIAX CLAVICLE HOOK PLATE Stryker Trauma AG
K140769 03/27/2014 VARIAX 2 SYSTEM Stryker Trauma AG
K141677 06/23/2014 VARIAX ELBOW PLATING SYSTEM Stryker Trauma AG
K132502 08/09/2013 VARIAX 2 SYSTEM Stryker Trauma AG
K143138 11/03/2014 AxSOS 3 Ti Locking Plate System Stryker Trauma AG
K133974 12/26/2013 VARIAX DISTAL RADIUS PLATING SYSTEM STRYKER LEIBINGER GMBH
K170507 02/21/2017 Invacare« 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 Maxx Invacare Corporation
K160630 03/07/2016 Invacare Platinum Mobile Oxygen Concentrator INVACARE CORPORATION
K181090 04/25/2018 Invacare« Solara« 3G and Solara« 3G Spree Manual Wheelchairs Invacare Corporation
K152536 09/04/2015 MyOn HC Manual Wheelchair INVACARE CORPORATION
K162621 09/20/2016 Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair Invacare Corporation
K162686 09/27/2016 Kuschall Champion Manual Wheelchair Invacare Corporation
K162692 09/27/2016 Kuschall K-Series Attract Manual Wheelchair INVACARE CORPORATION
K162696 09/27/2016 Kuschall Advance Manual Wheelchair INVACARE CORPORATION


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