Cleared Traditional

Flexx Junior (FLX-J00, FLX-J50)

K250576 · Karma Mobility Co, Ltd. · Physical Medicine

Nov 2025

Decision

250d

Days

Class 1

Risk

About This 510(k) Submission

K250576 is an FDA 510(k) clearance for the Flexx Junior (FLX-J00, FLX-J50), a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Karma Mobility Co, Ltd. (Khamthleso, TH). The FDA issued a Cleared decision on November 4, 2025, 250 days after receiving the submission on February 27, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K250576 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 2025
Decision Date	November 04, 2025
Days to Decision	250 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	IOR — Wheelchair, Mechanical
Device Class	Class I — General Controls
CFR Regulation	21 CFR 890.3850
Definition	A Mechanical Wheelchair Is A Manually Operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets ?mobility To Persons Restricted To A Sitting Position? To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And/or Require An Assistive Device For Mobility.