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CloudTMS for OCD Main unit

by Neurosoft, Ooo

CloudTMS for OCD Main unit is a Class II device made by Neurosoft, Ooo, cleared under FDA 510(k) K221129 on 10 Mar 2023 and listed in FDA GUDID since 14 Dec 2023 (UDI-DI 04650075333792), 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) K221129

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 Number04650075333792 UDI-DI Date14 Dec 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK221129 Date10 Mar 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K221129 decided 10 Mar 2023 Active
  • FDA GUDID UDI-DI 04650075333792 listed 14 Dec 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K221129
  2. Listed FDA GUDID 04650075333792

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CloudTMS for OCD
Generic name
Magnetic neural stimulation system
Model / reference
Main unit
Primary DI / UDI-DI
04650075333792
510(k) Number
FDA product code
QCI
GMDN term
Magnetic neural stimulation system
Device class
Class II
Regulation number
882.5802
GUDID distribution status
In Commercial Distribution

Related devices

Category: Magnetic neural stimulation system

Cleared under the same submission (K221129)

Similar devices in this category

Other devices filed under Magnetic neural stimulation system.

Other devices from Neurosoft, Ooo

See all devices from Neurosoft, Ooo →

Properties

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