Cleared Traditional

K243442 - iBOT® PMD (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K243442 · Mobius Mobility · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Jan 2025
Decision
85d
Days
Class 2
Risk

K243442 is an FDA 510(k) clearance for the iBOT® PMD. Classified as Wheelchair, Stair Climbing (product code IMK), Class II - Special Controls.

Submitted by Mobius Mobility (Manchester, US). The FDA issued a Cleared decision on January 30, 2025 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3890 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Mobius Mobility devices

Submission Details

510(k) Number K243442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2024
Decision Date January 30, 2025
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IMK Wheelchair, Stair Climbing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3890
Definition A Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. The Device Is Intended To Climb Stairs. 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 Require An Assistive Device For Mobility.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.