Cleared Traditional

K073330 - FREEDOM SCIENCES MOTION CONTROL MODULE (MCM)

K073330 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 Traditional 510(k) pathway after a 206-day FDA review.

K073330 · Freedom Sciences, LLC · Physical Medicine device
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Jun 2008
Decision
206d
Days
Class 2
Risk

K073330 is an FDA 510(k) clearance for the FREEDOM SCIENCES MOTION CONTROL MODULE (MCM). 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 June 20, 2008 after a review of 206 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 Freedom Sciences, LLC devices

FDA 510(k) Submission Details - K073330

510(k) Number K073330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2007
Decision Date June 20, 2008
Days to Decision 206 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 115d · This submission: 206d
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 297
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K073330.
HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT
K100350 · Hoveround Corp. · Mar 2010
JAZZY FRONTIE
K092961 · Pride Mobility Products Corp. · Oct 2009
HOVEROUND TEKNIQUE FWD MK4 POWER WHEELCHAIR
K090108 · Hoveround Corp. · Mar 2009
A-SERIES INTEGRAL CONTROLLER, MODEL INT/DL40I
K073134 · Invacare Corporation · Nov 2007
HEARTWAY LIGHTWEIGHT POWER CHAIR, P15
K071005 · Heartway Medical Products Co., Ltd. · May 2007
HEARTWAY ATTENDANT-CONTROLLED POWER CHAIR, TC1
K071006 · Heartway Medical Products Co., Ltd. · May 2007