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Jay Encompass Back

by Sunrise Medical (US) LLC

Jay Encompass Back is a gel-filled chair cushion (FDA Class I; FDA product code IMP, Cushion, Wheelchair) made by Sunrise Medical (US) LLC, listed in FDA GUDID since 12 Sep 2023 (UDI-DI 00016958053135), registry data as of 15 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 15 Oct 2026.

Regulatory status

as of registry sync 15 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00016958053135 UDI-DI Date12 Sep 2023ListedStatusListed 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  • Withdrawn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

Generic name
Gel-filled chair cushion
Model / reference
Encompass
Primary DI / UDI-DI
00016958053135
FDA product code
IMP
GMDN term
Gel-filled chair cushion
Device class
Class I
Regulation number
890.3920
GUDID distribution status
In Commercial Distribution

Similar devices

Other devices filed under FDA product code IMP (Cushion, Wheelchair).

Other devices from Sunrise Medical (US) LLC

See all devices from Sunrise Medical (US) LLC →

Properties

  • Over-the-counter
  • Premarket exempt
  • Manufacturing date
Other properties (12, all answered No)