Flexx Junior (FLX-J00, FLX-J50)— 510(k) K250576

Substantially Equivalent

Karma Mobility Co, Ltd.

FDA 510(k) clearance K250576 for Flexx Junior (FLX-J00, FLX-J50), Substantially Equivalent on 2025-11-04. Applicant: Karma Mobility Co, Ltd..

Clearance details

Applicant: Karma Mobility Co, Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2025-02-27
Decision date: 2025-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Khamthleso, TH

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.