K230782
- 510(k) number
- K230782
- Device name
- TENS device-HeadaTerm 2 (Model: YF-HT2)
- Applicant
- Wat Medical Technology, Inc. CN
- Product code
- PCC — Stimulator, Nerve, Electrical, Transcutaneous, For M
- Decision date
- 2024-02-26
- Date received
- 2023-03-22
- 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: K230782.pdf
Official FDA record: K230782
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.