Medical Device Manufacturer · US , Elyria , OH

Invacare Corp. - FDA 510(k) Cleared Devices

111 submissions · 110 cleared · Since 1980

111

Total

110

Cleared

Denied

Invacare Corp., is a healthcare company headquartered in Elyria, Ohio, specializing in mobility and respiratory care solutions. The company develops healthcare and lifestyle products focused on safety, quality, and performance for users with reduced movement.

Invacare has received 110 FDA 510(k) clearances from 111 total submissions since its first clearance in 1980. The company's cleared devices span Physical Medicine and anesthesiology categories, including power wheelchairs, mobility scooters, standing devices, and respiratory masks. The latest FDA 510(k) clearance was in 2007, reflecting the company's historical regulatory record in these device categories.

Notable cleared products include the Storm TDX Power Wheelchair, Adventure Series Scooters, EasyStand Evolv standing device, and respiratory products such as the Polaris EX CPAP and heated humidifier systems. These devices demonstrate the company's focus on mobility aids and respiratory support technologies.

Explore the complete list of device names, product codes, and clearance dates in the database to review Invacare's full regulatory history.

FDA 510(k) Regulatory Record - Invacare Corp.

111 devices

1-12 of 111