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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 116d · 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 549
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K073330.
P & F POWER WHEELCHAIR, MODEL HC-500SB
K082722 · P & F Brother Ind., Corp. · Oct 2008
HAIDA HD21
K082288 · Jiangyin East China Medical Technology Co., Ltd. · Aug 2008
K450 POWERED WHEELCHAIR
K081964 · Permobil AB · Jul 2008
CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR
K080385 · E1 Ent., Inc. · May 2008
TACAHE PC1350 POWER WHEELCHAIR
K080373 · Dalton Medical Corp. · Apr 2008
C.T.M. POWER CHAIR, MODEL HS-1500
K073686 · C.T.M. Homecare Product, Inc. · Feb 2008
K073330 · FREEDOM SCIENCES MOTION CONTROL MODULE (MCM)
Download PDF FDA Summary Freedom Sciences, LLC