K242719
- 510(k) number
- K242719
- Device name
- ELEXIR 2.0 (ALLIVE3)
- Applicant
- Nu Eyne Co., Ltd. KR
- Product code
- PCC — Stimulator, Nerve, Electrical, Transcutaneous, For M
- Decision date
- 2024-11-06
- Date received
- 2024-09-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K242719.pdf
Official FDA record: K242719
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.