Cleared Traditional

K153636 - Liberator Powered Wheelchair with Solar Companion

K153636 is an FDA 510(k) clearance for Liberator Powered Wheelchair with Solar..., manufactured by Solar Mobilityllc. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K153636 · Solar Mobilityllc · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
266d
Days
Class 2
Risk

K153636 is an FDA 510(k) clearance for the Liberator Powered Wheelchair with Solar Companion. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Solar Mobilityllc (Kennewick, US). The FDA issued a Cleared decision on September 9, 2016 after a review of 266 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.

FDA 510(k) Submission Details - K153636

510(k) Number K153636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2015
Decision Date September 09, 2016
Days to Decision 266 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
150d slower than avg
Panel avg: 116d · This submission: 266d
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 Consultant

Smith Associates
E.J SMITH

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 549
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K153636.
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K153636 · Liberator Powered Wheelchair with Solar Companion
Download PDF FDA Summary Solar Mobilityllc