Cleared Abbreviated

K032731 - MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS

K032731 is an FDA 510(k) clearance for MERLEXI CRAFT SERIES OF MANUAL (MECHANI..., manufactured by Turbo Wheelchair Co., Inc.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Abbreviated 510(k) pathway after a 57-day FDA review.

K032731 · Turbo Wheelchair Co., Inc. · Physical Medicine device
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Oct 2003
Decision
57d
Days
Class 1
Risk

K032731 is an FDA 510(k) clearance for the MERLEXI CRAFT SERIES OF MANUAL (MECHANICAL) WHEELCHAIRS. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Turbo Wheelchair Co., Inc. (Beaufort, US). The FDA issued a Cleared decision on October 30, 2003 after a review of 57 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Turbo Wheelchair Co., Inc. devices

FDA 510(k) Submission Details - K032731

510(k) Number K032731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2003
Decision Date October 30, 2003
Days to Decision 57 days
Submission Type Abbreviated
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
59d faster than avg
Panel avg: 116d · This submission: 57d
Pathway characteristics
Standards-based clearance path.

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 342
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K032731.
MANUAL WHEELCHAIR SERIES
K040561 · Shanghai Wheelchair Factory · Mar 2004
CHEETAH WHEELCHAIR
K033460 · R82 A/S · Mar 2004
TAIWAN KING STRONG TC 03 MECHANICAL WHEELCHAIR
K033031 · Taiwan King Strong Co., Ltd. · Dec 2003
HANDIVIPP
K033125 · Handinor USA, Inc. · Oct 2003
MECHANICAL WHEEHCHAIR
K033141 · Pacific Medical Suppliers, Inc. · Oct 2003
RODEO MODEL, RD12, RD14, RD16, RADIO TRANSIT MODEL, RD12T, RD14T, RD16T,
K032402 · Convaid Products, Inc. · Sep 2003