Cleared Traditional

K011701 - BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR

K011701 is an FDA 510(k) clearance for BIOTECH MANUAL WHEELCHAIR C650 SERIES T..., manufactured by Taiwan Armada Enterprise Co., Ltd.. The device is a Class 1 Physical Medicine device with product code IOR cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K011701 · Taiwan Armada Enterprise Co., Ltd. · Physical Medicine device
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Jun 2001
Decision
21d
Days
Class 1
Risk

K011701 is an FDA 510(k) clearance for the BIOTECH MANUAL WHEELCHAIR C650 SERIES TOUR LIGHT WHEELCHAIR. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Taiwan Armada Enterprise Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on June 22, 2001 after a review of 21 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 Armada Enterprise Co., Ltd. devices

FDA 510(k) Submission Details - K011701

510(k) Number K011701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2001
Decision Date June 22, 2001
Days to Decision 21 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
94d faster than avg
Panel avg: 115d · This submission: 21d
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 196
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K011701.
MEDLINE EXCEL RECLINCER WHEELCHAIR
K013761 · Medline Industries, Inc. · Dec 2001
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