510(k) K250689— CloudTMS Edge

Substantially Equivalent

Teleemg, LLC

Clearance details

Applicant: Teleemg, LLC
Product code: Code OBP
Advisory panel: Neurology
Date received: 2025-03-06
Decision date: 2025-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

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.