K242815
- 510(k) number
- K242815
- Device name
- POCKET TENS (EP-300)
- Applicant
- Hivox Biotek, Inc. TW
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2024-12-17
- Date received
- 2024-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K242815.pdf
Official FDA record: K242815
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.