K231423
- 510(k) number
- K231423
- Device name
- Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500)
- Applicant
- Shenzhen Roundwhale Technology Co. , Ltd. CN
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2024-01-22
- Date received
- 2023-05-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K231423.pdf
Official FDA record: K231423
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.