Cleared Traditional

K031711 - TANGO, MODELS, BP1

K031711 is an FDA 510(k) clearance for TANGO, manufactured by American Bantex Corp.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K031711 · American Bantex Corp. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
199d
Days
Class 2
Risk

K031711 is an FDA 510(k) clearance for the TANGO, MODELS, BP1. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by American Bantex Corp. (Bountiful, US). The FDA issued a Cleared decision on December 18, 2003 after a review of 199 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 - K031711

510(k) Number K031711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2003
Decision Date December 18, 2003
Days to Decision 199 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
83d slower than avg
Panel avg: 116d · This submission: 199d
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 585
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K031711.
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
EPW FOLDABLE POWER WHEELCHAIR, EPW-03
K033206 · Emg Technology Co., Ltd. · Dec 2003
UB 140
K033827 · Rivertrail Mobility · Dec 2003
TAIWAN KING STRONG POWERED WHEELCHAIR, TP 01
K033100 · Taiwan King Strong Co., Ltd. · Dec 2003
K031711 · TANGO, MODELS, BP1
Download PDF FDA Summary American Bantex Corp.