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TrakStar Patient Management System Software Version 7.9 (Cloud)

by Neuronetics Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850005944980 UDI-DI Date11 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0142-2027 FDA Class II initiated 24 Aug 2026

    Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
TrakStar Patient Management System Software
Generic Name
Magnetic neural stimulation system
Model / Ref / Catalog
Version 7.9 (Cloud), 83-00097-000
Primary DI / UDI-DI
00850005944980
510(k) Number
FDA Product Code
OBP, QCI
GMDN Term
Magnetic neural stimulation system
Device Class
Class II
Regulation Number
882.5805, 882.5802
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K231926)

Other devices from Neuronetics Inc.

See all devices from Neuronetics Inc. →

Properties

  • Prescription Use

Other properties (13)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No