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Independence 324

by Eagle Parts & Products, Inc.

510(k) K990484

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 NumberK990484 Date25 Jun 1999ClearedStatusActive

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  • Withdrawn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, 21 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 Independence 324 is a powered wheelchair classified under device class II with product code ITI. It is a substantially equivalent device cleared through the traditional 510(k) pathway, as indicated by the FDA authorization and openFDA data specifying its device name as Wheelchair, Powered.

The device was manufactured by Eagle Parts & Products, Inc. and received FDA 510(k) clearance under K990484 on June 25, 1999, following a submission received on February 16, 1999. It is associated with the Physical Medicine advisory committee and regulation number 890.3860, and is identified by numerous FEI and registration numbers in the openFDA data.

Other devices from Eagle Parts & Products, Inc.

Questions

AI-generated answers, 21 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 INDEPENDENCE 324 used for?

    The INDEPENDENCE 324 is a powered wheelchair designed to provide mobility assistance for individuals with limited ambulation, enabling movement in indoor and outdoor environments through motorized propulsion.

  • How is the INDEPENDENCE 324 supplied and is it reusable?

    The INDEPENDENCE 324 is supplied as a fully assembled powered wheelchair unit intended for repeated use over time; it is not single-use and requires regular maintenance, battery charging, and servicing to ensure safe operation.

  • What regulatory pathway was used for the INDEPENDENCE 324?

    The INDEPENDENCE 324 received FDA 510(k) clearance through the traditional pathway under K990484, demonstrating substantial equivalence to a legally marketed predicate device, as confirmed by the decision date of June 25, 1999.