K232439
- 510(k) number
- K232439
- Device name
- Electrical Stimulator System
- Applicant
- Gymmax Technology Shenzen Co., Ltd. CN
- Product code
- NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Decision date
- 2024-03-21
- Date received
- 2023-08-14
- 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: K232439.pdf
Official FDA record: K232439
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.