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Merits P321B-Swmub

by Merits Health Products., Inc.

Merits P321B-Swmub is a wheelchair (FDA Class II; FDA product code ITI, Wheelchair, Powered) made by Merits Health Products., Inc., cleared under FDA 510(k) K011687 on 3 Aug 2001 and listed in FDA GUDID since 16 Jan 2020 (UDI-DI 04714379292909), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

510(k) K011687

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04714379292909 UDI-DI Date16 Jan 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK011687 Date3 Aug 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K011687 decided 3 Aug 2001 Active
  • FDA GUDID UDI-DI 04714379292909 listed 16 Jan 2020 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1504-2021 FDA Class II initiated 1 Apr 2021

    Seat baseplate pin has broken in the field.

Timeline

3 dated events

  1. Cleared FDA 510(k) K011687
  2. Listed FDA GUDID 04714379292909
  3. Recall initiated FDA recalls Z-1504-2021

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Merits
Generic name
Wheelchair, power-assisted, occupant-controlled, non-collapsible
Model / reference
P321B-SWMUB
Primary DI / UDI-DI
04714379292909
510(k) Number
FDA product code
ITI
GMDN term
Wheelchair, power-assisted, occupant-controlled, non-collapsible
Device class
Class II
Regulation number
890.3860
GUDID distribution status
In Commercial Distribution

Related devices

Category: Wheelchair, power-assisted, occupant-controlled, non-collapsible

Cleared under the same submission (K011687)

and 8 more cleared under K011687

Similar devices

Other devices filed under FDA product code ITI (Wheelchair, Powered).

Other devices from Merits Health Products., Inc.

See all devices from Merits Health Products., Inc. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)