Cleared Traditional

Y.E.S. POWERED WHEELCHAIR, MODEL T200 (K032669) - FDA 510(k) Clearance

Class I Physical Medicine device.

K032669 · Yeou Eir Shuen Machinery Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
76d
Days
Class 1
Risk

K032669 is an FDA 510(k) clearance for the Y.E.S. POWERED WHEELCHAIR, MODEL T200. Classified as Splint, Denis Brown (product code ITN), Class I - General Controls.

Submitted by Yeou Eir Shuen Machinery Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on November 12, 2003 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3675 - 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.

View all Yeou Eir Shuen Machinery Co., Ltd. devices

Submission Details

510(k) Number K032669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2003
Decision Date November 12, 2003
Days to Decision 76 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 115d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ITN Splint, Denis Brown
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3675
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.