K231569
- 510(k) number
- K231569
- Device name
- ManaFlexx 2 (model: MF002-RX, MF002-OTC)
- Applicant
- Manamed, Inc. NV · US
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2023-11-03
- Date received
- 2023-05-31
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231569.pdf
Official FDA record: K231569
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.