Cleared Traditional

K010094 - A & I WHEELCHAIRS

K010094 is an FDA 510(k) clearance for A & I WHEELCHAIRS, manufactured by Taiwan an I Co., Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K010094 · Taiwan an I Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
35d
Days
Class 1
Risk

K010094 is an FDA 510(k) clearance for the A & I WHEELCHAIRS. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Taiwan an I Co., Ltd. (Chia-Yi Shiann, TW). The FDA issued a Cleared decision on February 15, 2001 after a review of 35 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.

View all Taiwan an I Co., Ltd. devices

FDA 510(k) Submission Details - K010094

510(k) Number K010094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2001
Decision Date February 15, 2001
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
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 168
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K010094.
SOLARA JR. MANUAL WHEELCHAIR
K012370 · Invacare Corp. · Aug 2001
MODEL TOP END TERMINATOR TITANIUM MANUAL WHEELCHAIR
K012167 · Invacare Corp. · Aug 2001
BREEZY WHEELCHAIR, MODEL 300
K011268 · Sunrise Medical, Inc. · May 2001
MODEL 9000 BARIATRIC WHEELCHAIR
K002317 · Invacare Corp. · Aug 2000
MODEL 9000 PEDIATRIC WHEELCHAIR
K002170 · Invacare Corp. · Aug 2000
ACTION AF-1 WHEELCHAIR
K000174 · Invacare Corp. · Feb 2000