Cleared Special

K091723 - FREEDOM SCIENCES MOTION CONTROL MODULE VERSION 1.5

K091723 is an FDA 510(k) clearance for FREEDOM SCIENCES MOTION CONTROL MODULE ..., manufactured by Freedom Sciences, LLC. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Special 510(k) pathway after a 25-day FDA review.

K091723 · Freedom Sciences, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
25d
Days
Class 2
Risk

K091723 is an FDA 510(k) clearance for the FREEDOM SCIENCES MOTION CONTROL MODULE VERSION 1.5. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Freedom Sciences, LLC (Cleveland, US). The FDA issued a Cleared decision on July 6, 2009 after a review of 25 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K091723

510(k) Number K091723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2009
Decision Date July 06, 2009
Days to Decision 25 days
Submission Type Special
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
91d faster than avg
Panel avg: 116d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 549
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K091723.
JAZZY FRONTIE
K092961 · Pride Mobility Products Corp. · Oct 2009
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K090108 · Hoveround Corp. · Mar 2009
QUICKIE RHYTHM
K083249 · Sunrise Medical Hhg, Inc. · Dec 2008
K091723 · FREEDOM SCIENCES MOTION CONTROL MODULE VERSION 1.5
Download PDF FDA Summary Freedom Sciences, LLC