Cleared Traditional

K011053 - OPTIMA

K011053 is an FDA 510(k) clearance for OPTIMA, manufactured by Medical Industries America, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K011053 · Medical Industries America, Inc. · Physical Medicine device
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Apr 2001
Decision
14d
Days
Class 2
Risk

K011053 is an FDA 510(k) clearance for the OPTIMA. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Medical Industries America, Inc. (Adel, US). The FDA issued a Cleared decision on April 20, 2001 after a review of 14 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 Medical Industries America, Inc. devices

FDA 510(k) Submission Details - K011053

510(k) Number K011053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2001
Decision Date April 20, 2001
Days to Decision 14 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
102d faster than avg
Panel avg: 116d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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

Citech
ROBERT MOSENKIS

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 499
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K011053.
AMYSEAT TILT/RECLINE SEATING
K011006 · Amysystems · May 2001
REGAL MOTOTRIZED 3 WHEELED VEHICLE
K011227 · Bruno Independent Living Aids, Inc. · May 2001
MP3HD BIG BOY, POWER WHEELCHAIR
K010380 · Merits Health Products., Inc. · May 2001
THE LIBERATOR WHEELCHAIR
K010859 · Liberator Wheelchairs, Inc. · Apr 2001
MCC-MIV ONE 2 ONE SOFTWARE
K010364 · Invacare Corp. · Mar 2001
E MOTION WHEELCHAIR DRIVE SYSTEM (POWER-ASSIST FOR MANUAL WHEELCHAIRS)
K003449 · Ulrich Alber GmbH & Co. · Mar 2001

FDA 510(k) Resources - Physical Medicine

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