Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs— 510(k) K181090

Substantially Equivalent

Invacare Corporation

FDA 510(k) clearance K181090 for Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs, Substantially Equivalent on 2018-11-14. Applicant: Invacare Corporation.

Clearance details

Applicant: Invacare Corporation
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2018-04-25
Decision date: 2018-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elyria, OH, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.