K250689
- 510(k) number
- K250689
- Device name
- CloudTMS Edge
- Applicant
- Teleemg, LLC CA · US
- Product code
- OBP — Transcranial Magnetic Stimulator
- Decision date
- 2025-09-14
- Date received
- 2025-03-06
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
510(k) Summary (official FDA PDF): K250689.pdf
Official FDA record: K250689
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.