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Quantum Bariatric 451

by Pride Mobility Product Corporration

510(k) K112815

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

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 · Special NumberK112815 Date29 Feb 2012ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2842-2026 FDA Class II initiated 25 Jun 2026
    • Ongoing Z-2847-2026 FDA Class II initiated 25 Jun 2026

    If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs while driving the wheelchair, the wheelchair may perform an unexpected park brake stop, which may result in fall or injury. If this occurs while not driving the wheelchair, the control system may crash and remain in pre-operational mode.

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  • Withdrawn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, 22 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 Quantum Bariatric 451 is a powered wheelchair. It is classified as a powered wheelchair device intended to provide mobility assistance.

This device is regulated as a Class II medical device under 21 CFR 890.3860 and received FDA 510(k) clearance. It is identified by product code ITI and is manufactured by Pride Mobility Product Corporration.

Other devices from Pride Mobility Product Corporration

Questions

AI-generated answers, 22 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 primary purpose of the Quantum Bariatric 451?

    The Quantum Bariatric 451 is a powered wheelchair specifically intended to provide mobility assistance to users.

  • How is this device classified for regulatory purposes?

    This device is regulated as a Class II medical device under 21 CFR 890.3860 and has received FDA 510(k) clearance under product code ITI.

  • Who is the manufacturer of this wheelchair?

    The Quantum Bariatric 451 is manufactured by Pride Mobility Product Corporration, based in Exeter, Pennsylvania.