Cleared Traditional

K250576 - Flexx Junior (FLX-J00

K250576 is an FDA 510(k) clearance for Flexx Junior (FLX-J00, manufactured by Karma Mobility Co, Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 250-day FDA review.

K250576 · Karma Mobility Co, Ltd. · Physical Medicine device
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Nov 2025
Decision
250d
Days
Class 1
Risk

K250576 is an FDA 510(k) clearance for the Flexx Junior (FLX-J00, FLX-J50). Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Karma Mobility Co, Ltd. (Khamthleso, TH). The FDA issued a Cleared decision on November 4, 2025 after a review of 250 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Karma Mobility Co, Ltd. devices

FDA 510(k) Submission Details - K250576

510(k) Number K250576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 115d · This submission: 250d
Pathway characteristics
Predicate-based equivalence.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IOR Wheelchair, Mechanical

All 92
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K250576.
Manual Wheelchair (W45)
K252825 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Dec 2025
Manual Wheelchair (W47)
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Manual Wheelchair (HM305-Air1, HM305-Air2)
K252687 · Suzhou Master Machinery Manufacturing Co.,Ltd · Nov 2025
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K252517 · Ningbo Shenyu Medical Equipment Co.,Ltd · Oct 2025
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Bowhead ERA Wheelchairs
K243111 · Bowhead Design Corp. · Jan 2025