Cleared Traditional

K000204 - WIN-1 TANGO

K000204 is an FDA 510(k) clearance for WIN-1 TANGO, manufactured by Duracare Medical Equipment, L.C.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 193-day FDA review.

K000204 · Duracare Medical Equipment, L.C. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
193d
Days
Class 2
Risk

K000204 is an FDA 510(k) clearance for the WIN-1 TANGO. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Duracare Medical Equipment, L.C. (Phoenix, US). The FDA issued a Cleared decision on August 1, 2000 after a review of 193 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K000204

510(k) Number K000204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2000
Decision Date August 01, 2000
Days to Decision 193 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
77d slower than avg
Panel avg: 116d · This submission: 193d
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 596
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K000204.
REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800
K001923 · Gendron, Inc. · Aug 2000
RANGER II M6, MODEL IN-888WNL
K002157 · Invacare Corp. · Aug 2000
MAGIC MOBILITY 4 X 4 WHEELCHAIR
K000796 · Vestil Manufacturing Corp. · Aug 2000
MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS
K001777 · Invacare Corp. · Jul 2000
T-2000-POWER TILT SEATING SYSTEM, MODELS ARD-TSTORM, ARD-TP-320, ARD-TG424, ARD-TS525, ARD-TJAZZY, ARD-TLANCER
K992804 · Accelerated Rehab Designs, Inc. · Feb 2000
E-2000 POWER ELEVATING SEAT SYSTEM, MODELS ARD-ESTORM, ARD-EP320, ARD-ELANCER
K992828 · Accelerated Rehab Designs, Inc. · Feb 2000
K000204 · WIN-1 TANGO
Download PDF FDA Summary Duracare Medical Equi…