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Setmark Incorporated TR-148

by Setmark Inc.

Setmark Incorporated TR-148 is a hospital stretcher (FDA Class II; FDA product code FPO, Stretcher, Wheeled) made by Setmark Inc., listed in FDA GUDID since 31 Jan 2018 (UDI-DI 00865388000444), registry data as of 22 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00865388000444 UDI-DI Date31 Jan 2018ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
Setmark Incorporated
Generic name
Hospital stretcher, manual
Model / reference
TR-148
Primary DI / UDI-DI
00865388000444
FDA product code
FPO
GMDN term
Hospital stretcher, manual
Device class
Class II
Regulation number
880.6910
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Hospital stretcher, manual

Similar devices in this category

Other devices filed under Hospital stretcher, manual.

Other devices from Setmark Inc.

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Properties

  • Premarket exempt
  • Lot / batch number
  • Serial number
Other properties (12, all answered No)