K233054
- 510(k) number
- K233054
- Device name
- Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator; TENS/EMS WITH Menstrual Relief Stimulator; Well-Life Pain Relief Stimulator; Menstrual Plus Stimulator
- Applicant
- Well-Life Healthcare Limited TW
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2024-10-18
- Date received
- 2023-09-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K233054.pdf
Official FDA record: K233054
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.