FDA Product Code
FDA Product Code QHH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Gastroenterology, Urology
- 21 CFR Citation
- 876.5340
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252024 | NeurAxis IB-Stim (01-1020) | Neuraxis | 2025-10-16 | Traditional | PDF ↗ |
| K250451 | NeurAxis IB-Stim (01-1020) | Neuraxis | 2025-05-15 | Traditional | PDF ↗ |
| K241533 | NeurAxis IB-Stim (01-1020) | Neuraxis | 2024-10-30 | Traditional | PDF ↗ |
| K230526 | TEA Device | Transtimulation Research, Inc. | 2023-09-14 | Traditional | PDF ↗ |
| K202940 | First Relief v1 | Dyansys, Inc. | 2020-12-29 | Traditional | PDF ↗ |
| DEN180057 | IB-Stim | Innovative Health Solutions (Ihs), Inc. | 2019-06-07 | Direct | — |
Product code QHH · Class II · Gastroenterology, Urology. Data: openFDA.