Cleared Traditional

K170507 - Invacare® TDX® SP2 Power Wheelchair

Also marketed or referenced as:
TDXSP2 TDX SP2 with LiNX Electronics, TDXSP2-CG TDX SP2 Base for Single Act. System w/ Ultra Low Maxx, TDXSP2-MCG TDX SP2 Base for Multiple Actuator System w/ Ultra Low Maxx

K170507 is an FDA 510(k) clearance for Invacare TDX SP2 Power Wheelchair, manufactured by Invacare Corporation. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K170507 · Invacare Corporation · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
141d
Days
Class 2
Risk

K170507 is an FDA 510(k) clearance for the Invacare® TDX® SP2 Power Wheelchair. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Invacare Corporation (Elyria, US). The FDA issued a Cleared decision on July 12, 2017 after a review of 141 days - within the typical 510(k) review window.

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.

View all Invacare Corporation devices

FDA 510(k) Submission Details - K170507

510(k) Number K170507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2017
Decision Date July 12, 2017
Days to Decision 141 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
26d slower than avg
Panel avg: 115d · This submission: 141d
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 375
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K170507.
SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP
K173313 · Eurogreen International, Inc. · Feb 2018
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