K230526
- 510(k) number
- K230526
- Device name
- TEA Device
- Applicant
- Transtimulation Research, Inc. OK · US
- Product code
- QHH — Non-Implanted Nerve Stimulator For Pain Associated W
- Decision date
- 2023-09-14
- Date received
- 2023-02-27
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K230526.pdf
Official FDA record: K230526
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.