PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT— 510(k) K083231

Substantially Equivalent

Panthera Production AB

FDA 510(k) clearance K083231 for PANTHERA MECHANICAL WHEELCHAIR, MODELS S2, U2, BAMBINO, MICRO, BT, Substantially Equivalent on 2009-01-26. Applicant: Panthera Production AB.

Clearance details

Applicant: Panthera Production AB
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2008-11-03
Decision date: 2009-01-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.