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Neurosoft TMS

by Neurosoft, Ooo

Neurosoft TMS is a Class II device made by Neurosoft, Ooo, cleared under FDA 510(k) K160309 on 22 Dec 2016 and listed in FDA GUDID since 5 Jun 2017 (UDI-DI 04650075330197), active as of 23 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 23 Oct 2026

Documents

510(k) K160309

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 Number04650075330197 UDI-DI Date5 Jun 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK160309 Date22 Dec 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K160309 decided 22 Dec 2016 Active
  • FDA GUDID UDI-DI 04650075330197 listed 5 Jun 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K160309
  2. Listed FDA GUDID 04650075330197

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Neurosoft
Generic name
Magnetic neural stimulation system
Model / reference
TMS
Primary DI / UDI-DI
04650075330197
510(k) Number
FDA product code
OBP
GMDN term
Magnetic neural stimulation system
Device class
Class II
Regulation number
882.5805
GUDID distribution status
In Commercial Distribution

Related devices

Category: Magnetic neural stimulation system

Similar devices in this category

Other devices filed under Magnetic neural stimulation system.

Other devices from Neurosoft, Ooo

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Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)