K232675
- 510(k) number
- K232675
- Device name
- Heating Tens, FT-615
- Applicant
- Hivox Biotek, Inc. TW
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2023-10-05
- Date received
- 2023-09-01
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232675.pdf
Official FDA record: K232675
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.