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Setmark Incorporated WC-116

by Setmark Inc.

Setmark Incorporated WC-116 is a bariatric transport wheelchair (FDA Class I; FDA product code IOR, Wheelchair, Mechanical) made by Setmark Inc., cleared under FDA 510(k) K973418 on 9 Oct 1997 and listed in FDA GUDID since 31 Jan 2018 (UDI-DI 00854204008092), active as of 22 Oct 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K973418

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00854204008092 UDI-DI Date31 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK973418 Date9 Oct 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K973418 decided 9 Oct 1997 Active
  • FDA GUDID UDI-DI 00854204008092 listed 31 Jan 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K973418
  2. Listed FDA GUDID 00854204008092

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Setmark Incorporated
Generic name
Bariatric transport wheelchair, collapsible
Model / reference
WC-116
Primary DI / UDI-DI
00854204008092
510(k) Number
FDA product code
IOR
GMDN term
Bariatric transport wheelchair, collapsible
Device class
Class I
Regulation number
890.3850
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Bariatric transport wheelchair, collapsible

Cleared under the same submission (K973418)

and 8 more cleared under K973418

Similar devices

Other devices filed under FDA product code IOR (Wheelchair, Mechanical).

Other devices from Setmark Inc.

See all devices from Setmark Inc. →

Properties

  • Lot / batch number
  • Serial number
Other properties (13, all answered No)