Skip to content

ImmersiveTouch ImmersiveTouch4

by ImmersiveTouch, Inc.

ImmersiveTouch ImmersiveTouch4 is a Class II device made by ImmersiveTouch, Inc., cleared under FDA 510(k) K140860 on 16 Dec 2014 and listed in FDA GUDID since 7 Aug 2020 (UDI-DI B940IVZBKIT0), 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) K140860

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 NumberB940IVZBKIT0 UDI-DI Date7 Aug 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK140860 Date16 Dec 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140860 decided 16 Dec 2014 Active
  • FDA GUDID UDI-DI B940IVZBKIT0 listed 7 Aug 2020 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2041-2020 FDA Class III initiated 3 Apr 2020

    Observed an internal repetitive software glitch in ImmersiveView.

Timeline

3 dated events

  1. Cleared FDA 510(k) K140860
  2. Recall initiated FDA recalls Z-2041-2020
  3. Listed FDA GUDID B940IVZBKIT0

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ImmersiveTouch
Generic name
Portable computer
Model / reference
ImmersiveTouch4
Primary DI / UDI-DI
B940IVZBKIT0
510(k) Number
FDA product code
LLZ
GMDN term
Portable computer
Device class
Class II
Regulation number
892.2050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Portable computer

Cleared under the same submission (K140860)

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

Other devices from ImmersiveTouch, Inc.

  • ImmersiveAR V2.0

    Class II

  • ImmersiveTouch V5.0

    Class II

  • ImmersiveTouch V3.0 Open recall

    Class II

  • Ikshana V1.0

    Class II

See all devices from ImmersiveTouch, Inc. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)