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

Name: FDA 510(k) clearance K250576
Creator: U.S. Food and Drug Administration
Published: 2025-11-04

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.. Device class: 1.

Clearance details

Applicant: Karma Mobility Co, Ltd.
Product code: Code IOR
Device class: Class 1
Regulation: 21 CFR 890.3850
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 ↗

Recent devices under product code IOR

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K261571 — Manual Wheelchair (H008, PCK7)2026-08-06
K252370 — GEN 4 JOY Wheelchair2026-07-24
K261075 — Manual Wheelchair (MS01); Manual Wheelchair (MA01)2026-06-22
K261076 — Caregiver-assisted wheelchair (MS02); Caregiver-assisted wheelchair (MA02)2026-06-22
K260849 — ICON 35; ICON 45; ICON 60; ICON 30FAF2026-06-11

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.