Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T— 510(k) K171017

Substantially Equivalent

Convaid Products, LLC

FDA 510(k) clearance K171017 for Convaid Flyer FL12, FL13, FL14, FL15 and FL16; Convaid Flyer transit FL12T, FL13T, FL14T, FL15T and FL16T, Substantially Equivalent on 2017-10-18. Applicant: Convaid Products, LLC.

Clearance details

Applicant: Convaid Products, LLC
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2017-04-05
Decision date: 2017-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

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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.