Cleared Traditional

K231032 - AMP by Method Mobility, AMP Plus (or +) by Method Mobility (FDA 510(k) Clearance)

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

K231032 · Method Mobility · Physical Medicine device
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May 2023
Decision
29d
Days
Class 2
Risk

K231032 is an FDA 510(k) clearance for the AMP by Method Mobility, AMP Plus (or +) by Method Mobility. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Method Mobility (Fresno, US). The FDA issued a Cleared decision on May 10, 2023 after a review of 29 days - a notably fast clearance 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: 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 Method Mobility devices

Submission Details

510(k) Number K231032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2023
Decision Date May 10, 2023
Days to Decision 29 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 115d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 Consultant

Third Party Review Group, LLC
Dave Yungvirt

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ITI Wheelchair, Powered

All 574
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K231032.
Power Wheelchair (N5919 series)
K253806 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Apr 2026
Power Wheelchair (OS-R-M01S)
K253952 · Beijing OrionStar Technology Co., Ltd. · Apr 2026
Electric Wheelchair (AL-208S-063)
K253340 · Zhongshan A&J Medical Equipment Co., Ltd. · Apr 2026
Electric wheelchair
K253307 · Foshan Dahao Medical Technology Co., Ltd. · Mar 2026
Electrically Powered Wheelchair (Model YC-01)
K253980 · Yurob Rehabilitation Medical Co., Ltd. · Mar 2026
Power wheelchair (ZS-EW8026)
K254206 · Ningbo Zhishan Medical Technology Co., Ltd. · Mar 2026

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.