Cleared Abbreviated

K993406 - TRAX

K993406 is the FDA 510(k) clearance for TRAX by Permobil AB. It is a Class 2 Physical Medicine device (product code ITI) cleared through the Abbreviated 510(k) pathway after a 437-day FDA review.

K993406 · Permobil AB · Physical Medicine device
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Dec 2000
Decision
437d
Days
Class 2
Risk

K993406 is an FDA 510(k) clearance for the TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Permobil AB (Sollentuna, SE). The FDA issued a Cleared decision on December 18, 2000 after a review of 437 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: High-complexity regulatory submission. Standards-verified equivalence. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Permobil AB devices

Submission Details

510(k) Number K993406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1999
Decision Date December 18, 2000
Days to Decision 437 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
322d slower than avg
Panel avg: 115d · This submission: 437d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 173
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K993406.
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MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS
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