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K-Tech 2 Power Tilt Seating System, Model K2PT

by Track Corporation

510(k) K033263

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK033263 Date31 Oct 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ITI
Device Class
Class II
Regulation
21 CFR Part 890.3860
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The K-Tech 2 Power Tilt Seating System, Model K2pt, is a powered seating system for power wheelchairs. It is designed to provide tilt-in-space functionality, allowing users to adjust their seating position. The system is installed by qualified dealers and can be controlled via a low-amp toggle switch or optional specialty controls.

The K-Tech 2 Power Tilt Seating System, Model K2pt, is supplied as an aftermarket system and is intended for use with power wheelchairs. It has a regulation number of 890.3860 and is classified as a Class 2 device. The system is designed to be substantially equivalent to existing devices and has been cleared by the FDA through a traditional clearance process.

Questions

AI-generated answers, 27 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the K-Tech 2 Power Tilt Seating System used for?

    The K-Tech 2 Power Tilt Seating System is used to provide tilt-in-space functionality for power wheelchairs, allowing users to adjust their seating position.

  • How is the K-Tech 2 Power Tilt Seating System controlled?

    The system can be controlled via a low-amp toggle switch or optional specialty controls.

  • Is the K-Tech 2 Power Tilt Seating System supplied as an original equipment or aftermarket system?

    The K-Tech 2 Power Tilt Seating System is supplied as an aftermarket system, intended for use with power wheelchairs.