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Mobi 70117

by Mobi Technologies, Inc.

Mobi 70117 is a Class II device made by Mobi Technologies, Inc., cleared under FDA 510(k) K161735 on 17 Nov 2016 and listed in FDA GUDID since 28 Mar 2022 (UDI-DI 00891040701176), 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) K161735

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 Number00891040701176 UDI-DI Date28 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK161735 Date17 Nov 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K161735 decided 17 Nov 2016 Active
  • FDA GUDID UDI-DI 00891040701176 listed 28 Mar 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K161735
  2. Listed FDA GUDID 00891040701176

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mobi
Generic name
Infrared patient thermometer, skin
Model / reference
70117
Primary DI / UDI-DI
00891040701176
510(k) Number
FDA product code
FLL
GMDN term
Infrared patient thermometer, skin
Device class
Class II
Regulation number
880.2910
GUDID distribution status
In Commercial Distribution

Related devices

Category: Infrared patient thermometer, skin

Cleared under the same submission (K161735)

and 1 more cleared under K161735

Similar devices in this category

Other devices filed under Infrared patient thermometer, skin.

Other devices from Mobi Technologies, Inc.

Properties

  • Over-the-counter
  • Lot / batch number
Other properties (13, all answered No)