Bambino 3, S3 and S3 Swing, U3 and U3 Light, X— 510(k) K220698

Substantially Equivalent

Panthera AB

FDA 510(k) clearance K220698 for Bambino 3, S3 and S3 Swing, U3 and U3 Light, X, Substantially Equivalent on 2023-02-16. Applicant: Panthera AB.

Clearance details

Applicant: Panthera AB
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2022-03-09
Decision date: 2023-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stockholm, SE

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.