K223729
- 510(k) number
- K223729
- Device name
- FLOWpresso
- Applicant
- Medella Health Limited NZ
- Product code
- IRP — Massager, Powered Inflatable Tube
- Decision date
- 2023-12-21
- Date received
- 2022-12-13
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K223729.pdf
Official FDA record: K223729
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.