K250309
- 510(k) number
- K250309
- Device name
- BTL-199
- Applicant
- BTL Industries, Inc. MA · US
- Product code
- QPL — Electromagnetic Stimulator, Pain Relief
- Decision date
- 2025-08-07
- Date received
- 2025-02-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K250309.pdf
Official FDA record: K250309
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.