Cleared Traditional

K040320 - SINON POWER WHEELCHAIR, SN-P401

K040320 is an FDA 510(k) clearance for SINON POWER WHEELCHAIR, manufactured by Sinon Corporation. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K040320 · Sinon Corporation · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
32d
Days
Class 2
Risk

K040320 is an FDA 510(k) clearance for the SINON POWER WHEELCHAIR, SN-P401. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Sinon Corporation (Hsin Chu City, TW). The FDA issued a Cleared decision on March 12, 2004 after a review of 32 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 - K040320

510(k) Number K040320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2004
Decision Date March 12, 2004
Days to Decision 32 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 116d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - ITI Wheelchair, Powered

All 589
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K040320.
A&I POWER WHEELCHAIR, PC-401
K041190 · Well Success Biotech, Inc. · May 2004
POWERED WHEELCHAIR
K033142 · Nats Corp. · May 2004
NOMAD FROM DYNAMIS MOBILITY LTD.
K040457 · Dynamis Mobility , Ltd. · May 2004
SINON POWER WHEELCHAIR, SN-W401
K040319 · Sinon Corporation · Feb 2004
C.T.M. POWER CHAIR, MODEL HS-1000
K040020 · C.T.M. Homecare Product, Inc. · Feb 2004
STREET
K032765 · Permobil AB · Jan 2004
K040320 · SINON POWER WHEELCHAIR, SN-P401
Download PDF FDA Summary Sinon Corporation