Neurosoft TMS (also CloudTMS)— 510(k) K173441

Substantially Equivalent

Teleemg, LLC

FDA 510(k) clearance K173441 for Neurosoft TMS (also CloudTMS), Substantially Equivalent on 2017-12-13. Applicant: Teleemg, LLC.

Clearance details

Applicant: Teleemg, LLC
Product code: Code OBP
Advisory panel: Neurology
Date received: 2017-11-06
Decision date: 2017-12-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OBP

product code OBP

Injury: 270
Total: 270

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.