K231440
- 510(k) number
- K231440
- Device name
- Combo Electrotherapy Device
- Applicant
- Shenzhen Roundwhale Technology Co. , Ltd. CN
- Product code
- IPF — Stimulator, Muscle, Powered
- Decision date
- 2023-11-03
- Date received
- 2023-05-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Physical Medicine
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K231440.pdf
Official FDA record: K231440
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.