Cleared Traditional

K033141 - MECHANICAL WHEEHCHAIR

K033141 is an FDA 510(k) clearance for MECHANICAL WHEEHCHAIR, manufactured by Pacific Medical Suppliers, Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K033141 · Pacific Medical Suppliers, Inc. · Physical Medicine device
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Oct 2003
Decision
30d
Days
Class 1
Risk

K033141 is an FDA 510(k) clearance for the MECHANICAL WHEEHCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Pacific Medical Suppliers, Inc. (Sound Beach, US). The FDA issued a Cleared decision on October 30, 2003 after a review of 30 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 - K033141

510(k) Number K033141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date October 30, 2003
Days to Decision 30 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 116d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

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 Peers - IOR Wheelchair, Mechanical

All 465
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K033141.
TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR
K033031 · Taiwan King Strong Co., Ltd. · Dec 2003
MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS
K032731 · Turbo Wheelchair Co., Inc. · Oct 2003
HANDIVIPP
K033125 · Handinor USA, Inc. · Oct 2003
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
K033141 · MECHANICAL WHEEHCHAIR
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