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Merits S1315-Sbmu

by Merits Health Products., Inc.

Merits S1315-Sbmu is an assistive scooter (FDA Class II; FDA product code INI, Vehicle, Motorized 3-Wheeled) made by Merits Health Products., Inc., cleared under FDA 510(k) K011751 on 6 Aug 2001 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 04714379291735), 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) K011751

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 Number04714379291735 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK011751 Date6 Aug 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K011751 decided 6 Aug 2001 Active
  • FDA GUDID UDI-DI 04714379291735 listed 12 Sep 2016 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1505-2021 FDA Class II initiated 1 Apr 2021

    Seat baseplate pin has broken in the field.

Timeline

3 dated events

  1. Cleared FDA 510(k) K011751
  2. Listed FDA GUDID 04714379291735
  3. Recall initiated FDA recalls Z-1505-2021

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  • Withdrawn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
Assistive scooter, electric-motor-driven
Model / reference
S1315-SBMU
Primary DI / UDI-DI
04714379291735
510(k) Number
FDA product code
INI
GMDN term
Assistive scooter, electric-motor-driven
Device class
Class II
Regulation number
890.3800
GUDID distribution status
In Commercial Distribution

Related devices

Category: Assistive scooter, electric-motor-driven

Cleared under the same submission (K011751)

and 8 more cleared under K011751

Similar devices

Other devices filed under FDA product code INI (Vehicle, Motorized 3-Wheeled).

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)