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Merits P326A-Sbmub

by Merits Health Products., Inc.

Merits P326A-Sbmub is a wheelchair (FDA Class II; FDA product code ITI, Wheelchair, Powered) made by Merits Health Products., Inc., cleared under FDA 510(k) K012802 on 18 Sep 2001 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 04714379290967), 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) K012802

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 Number04714379290967 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK012802 Date18 Sep 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K012802 decided 18 Sep 2001 Active
  • FDA GUDID UDI-DI 04714379290967 listed 12 Sep 2016 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) K012802
  2. Listed FDA GUDID 04714379290967
  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  • Withdrawn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
P326A-SBMUB
Primary DI / UDI-DI
04714379290967
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 (K012802)

and 8 more cleared under K012802

Other devices from Merits Health Products., Inc.

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

Properties

  • Combination product
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)