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Electrical Stimulation Box M014910

by Intelligent Hearing Systems Corp.

Electrical Stimulation Box M014910 is a Class II device made by Intelligent Hearing Systems Corp., cleared under FDA 510(k) K070608 on 18 Jul 2007 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00817020020297), 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) K070608

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 Number00817020020297 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK070608 Date18 Jul 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K070608 decided 18 Jul 2007 Active
  • FDA GUDID UDI-DI 00817020020297 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K070608
  2. Listed FDA GUDID 00817020020297

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Electrical Stimulation Box
Generic name
Somatosensory electrical stimulation system
Model / reference
M014910
Primary DI / UDI-DI
00817020020297
510(k) Number
FDA product code
GWF
GMDN term
Somatosensory electrical stimulation system
Device class
Class II
Regulation number
882.1870
GUDID distribution status
In Commercial Distribution

Related devices

Category: Somatosensory electrical stimulation system

Cleared under the same submission (K070608)

and 8 more cleared under K070608

Similar devices

Other devices filed under FDA product code GWF (Stimulator, Electrical, Evoked Response).

Other devices from Intelligent Hearing Systems Corp.

See all devices from Intelligent Hearing Systems Corp. →

Properties

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