K243290
- 510(k) number
- K243290
- Device name
- BTL-785MJ
- Applicant
- BTL Industries, Inc. MA · US
- Product code
- NUW — Stimulator, Muscle, Powered, Dental
- Decision date
- 2025-05-09
- Date received
- 2024-10-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K243290.pdf
Official FDA record: K243290
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.