Cleared Traditional

K021255 - Y.E.S 10 WHEELCHAIR

K021255 is an FDA 510(k) clearance for Y.E.S 10 WHEELCHAIR, manufactured by Movingpeople.Net. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K021255 · Movingpeople.Net · Physical Medicine device
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May 2002
Decision
13d
Days
Class 2
Risk

K021255 is an FDA 510(k) clearance for the Y.E.S 10 WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Movingpeople.Net (Toronto, Ontario, CA). The FDA issued a Cleared decision on May 2, 2002 after a review of 13 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.

FDA 510(k) Submission Details - K021255

510(k) Number K021255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2002
Decision Date May 02, 2002
Days to Decision 13 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
103d faster than avg
Panel avg: 116d · This submission: 13d
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

Tuv America, Inc.
MARK JOB

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 596
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K021255.
TIPOWER POWERDRIVE AND RIMPOWER X & SX
K020539 · Tisport · Jun 2002
TIPOWER TR RIMPOWER AND TIPOWER TRA RIMPOWER
K020639 · Tisport · Jun 2002
INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91
K021680 · Invacare Corp. · Jun 2002
TEKNIQUE-HOVEROUND POWER WHEEL CHAIR
K021136 · Hoveround Corp. · Apr 2002
KARMA DISCOVERY, MODEL KP40
K014127 · Vestil Manufacturing Corp. · Mar 2002
WIN-2 TANGO ELITE NP
K013361 · Durable Medical Equipment, Inc. · Feb 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.

K021255 · Y.E.S 10 WHEELCHAIR
Download PDF Movingpeople.Net