Cleared Traditional

K032133 - BRODA MODEL 587 MANUAL WHEELCHAIR

K032133 is an FDA 510(k) clearance for BRODA MODEL 587 MANUAL WHEELCHAIR, manufactured by Broda Ent., Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K032133 · Broda Ent., Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
10d
Days
Class 1
Risk

K032133 is an FDA 510(k) clearance for the BRODA MODEL 587 MANUAL WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Broda Ent., Inc. (Waterloo Ontario, CA). The FDA issued a Cleared decision on July 21, 2003 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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.

FDA 510(k) Submission Details - K032133

510(k) Number K032133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2003
Decision Date July 21, 2003
Days to Decision 10 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 116d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

IOR Device Classification - Class 1, General Controls

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3850
Definition A Mechanical Wheelchair Is A Manually 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/or Require An Assistive Device For Mobility.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Citech

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 - IOR Wheelchair, Mechanical

All 465
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K032133.
RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T,
K032402 · Convaid Products, Inc. · Sep 2003
SHOCKWAVE SUSPENSION WHEELCHAIR
K032123 · Per4max Medical, LLC · Jul 2003
STAINLESS STEEL AQUATIC WHEELCHAIR
K031910 · Db Perks & Associates , Ltd. · Jul 2003
CHUMP
K030017 · Colours 'N Motion · May 2003
GALAXY SERIES WHEELCHAIR
K023993 · Evermed Corp. · Dec 2002
TILITE EVO
K024055 · Tisport, LLC · Dec 2002

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.

K032133 · BRODA MODEL 587 MANUAL WHEELCHAIR
Download PDF FDA Summary Broda Ent., Inc.