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Unimode Power Module System

by Dufco Electronics, Inc. 510(k)

Active United States

510(k) K881462

Overview

The Unimode Power Module System is a powered wheelchair device classified under device class 2. It is identified by the device name UNIMODE(TM) POWER MODULE SYSTEM and the product code ITI.

The device received FDA 510(k) clearance under K881462 on July 18, 1988, with a traditional clearance type and substantially equivalent decision. It is manufactured by Dufco Electronics, Inc. and falls under the Physical Medicine advisory committee classification.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK881462 Date18 Jul 1988ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Unimode(Tm) Power Module System
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

Other devices from Dufco Electronics, Inc.

Questions

  • What is the Unimode Power Module System used for?

    The Unimode Power Module System is a powered wheelchair device designed for mobility assistance in physical medicine applications, providing powered movement for users requiring wheelchair support.

  • How is the Unimode Power Module System supplied or configured?

    The device is supplied as a powered wheelchair system under the product code ITI, manufactured by Dufco Electronics, Inc., and includes the power module components necessary for wheelchair operation as cleared in its 510(k) submission.

  • What regulatory pathway was used for the Unimode Power Module System?

    The device received FDA 510(k) clearance under submission K881462 on July 18, 1988, with a traditional clearance process and a substantially equivalent determination, indicating it met the requirements for market release based on comparison to a predicate device.