Medical device manufacturer
Invacare Corporation
Invacare Corporation holds 131 FDA 510(k) clearances across 20 product codes. Median elapsed review time is 82 days. openFDA lists 68 recall records naming the company. FDA publishes it under 7 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 131
- Product codes
- 20
- Median review
- 82 days
- Recall records
- 68
How does FDA spell Invacare Corporation?
FDA publishes this company under 7 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| INVACARE CORP. DBA INVACARE AMERICA | device/registrationlisting | normalised |
| Invacare Corp | device/recall | normalised |
| Invacare Corp. | device/510k | normalised |
| Invacare Corporation | device/enforcement | normalised |
| Invacare Corporation | device/recall | normalised |
| Invacare Corporation | device/510k | normalised |
| Invacare GmbH | device/registrationlisting | normalised |
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Invacare Corporation file in?
20 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| ITI | Wheelchair, Powered | 38 | 82 days | |
| IOR | Wheelchair, Mechanical | 32 | 20 days | |
| CAW | Generator, Oxygen, Portable | 20 | 110 days | |
| BXB | Exerciser, Powered | 8 | 74 days | |
| BZD | Ventilator, Non-Continuous (Respirator) | 5 | 187 days | |
| INI | Vehicle, Motorized 3-Wheeled | 5 | 12 days | |
| CAF | Nebulizer (Direct Patient Interface) | 4 | 87 days | |
| INO | Chair, Positioning, Electric | 4 | 35 days | |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 2 | 148 days | |
| FNL | Bed, Ac-Powered Adjustable Hospital | 2 | 50 days | |
| NFB | Conserver, Oxygen | 2 | 90 days | |
| BYJ | Unit, Liquid-Oxygen, Portable | 1 | 256 days | |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 | 220 days | |
| DPS | Electrocardiograph | 1 | 169 days | |
| FNM | Mattress, Air Flotation, Alternating Pressure | 1 | 49 days | |
| FSA | Lift, Patient, Non-Ac-Powered | 1 | 40 days | |
| IKZ | Bed, Patient Rotation, Powered | 1 | 91 days | |
| JFB | Table, Physical Therapy, Multi Function | 1 | 73 days | |
| KNN | Components, Wheelchair | 1 | 23 days | |
| LAW | Theophylline Control Materials | 1 | 123 days |
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Invacare Corporation had a recall?
openFDA lists 68 recall records naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-1251-2024Class IIOpen, ClassifiedLLI
Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components
Z-2445-2023Class IIOpen, ClassifiedITJ
Premature failure of the seat during use, the plastic eyelets of the folding mechanism of the device's seat can break, and in a worst-case crossbar also breaks and the Rollator can collapse causing injury to user
Z-1369-2022Class IIIOpen, ClassifiedCAW
Between March 2, 2021 and December 31, 2021, the product label used in production did not contain the "Rx Only" statement as required.
Z-1130-2022Class IIOpen, ClassifiedITI
The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to the wheelchair. The disconnection of the battery harness results in loss of power to the wheelchair.
Z-0445-2022Class IIOpen, ClassifiedITI
Power Wheelchairs with a LiNX Gyro component running firmware version 6.1.2 can experience a more aggressive deceleration rate than the programmed rate due to the system following the incorrect deceleration profile, resulting in potential injury
Showing the 5 most recently initiated of 68.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Invacare Corporation cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K203210 | Invacare Platinum 5NXG Oxygen Concentrator | CAW | 164 | |
| K202379 | Invacare AVIVA Storm RX Power Chair | ITI | 211 | |
| K200890 | Invacare Perfecto2V Oxygen Concentrator | CAW | 125 | |
| K192216 | Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP | ITI | 140 | |
| K191159 | 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 Concentrator with Connectivity | CAW | 120 | |
| K182946 | Invacare TDX SP2-HD with Captain's Seat | ITI | 49 | |
| K181090 | Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs | IOR | 203 | |
| K170507 | 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 | ITI | 141 | |
| K162621 | Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair | IOR | 209 | |
| K162696 | Kuschall Advance Manual Wheelchair | IOR | 92 |
Source: openFDA device/510k · retrieved
Where is Invacare Corporation registered?
FDA lists 2 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Invacare Corporation files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.