Cleared Traditional

K250819 - Electric Wheelchair (Rollz Motion Elect...

K250819 is an FDA 510(k) clearance for Electric Wheelchair (Rollz Motion Elect..., manufactured by Rollz International BV. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 234-day FDA review.

K250819 · Rollz International BV · Physical Medicine device
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Nov 2025
Decision
234d
Days
Class 2
Risk

K250819 is an FDA 510(k) clearance for the Electric Wheelchair (Rollz Motion Electric 2M). Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Rollz International BV (Delft, NL). The FDA issued a Cleared decision on November 7, 2025 after a review of 234 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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 Rollz International BV devices

FDA 510(k) Submission Details - K250819

510(k) Number K250819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2025
Decision Date November 07, 2025
Days to Decision 234 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d slower than avg
Panel avg: 115d · This submission: 234d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-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 Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
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.

Regulatory Peers - ITI Wheelchair, Powered

All 220
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K250819.
Electric Wheelchair (DH01126)
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Powered Wheelchair (PL001-9001)
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