510(k) K202940
- Device
- First Relief v1
- Applicant
- Dyansys, Inc.
- 510(k) number
- K202940
- Product code
- QHH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2020-12-29
- Date received
- 2020-09-30
- Regulation
- 876.5340
- Classification name
- Non-Implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (Ibs)
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Srini Nageshwar
- Address
- 300, N. Bayshore Blvd. San Mateo CA US 94401 94401
FDA Registration Numbers#
- 3011743372
- 3036040187
- 3001110146
- 3010350335
- 3009445917
Source Documents#
Other 510(k) Records For Product Code QHH#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252024 | NeurAxis IB-Stim (01-1020) | Neuraxis | 2025-10-16 |
| K250451 | NeurAxis IB-Stim (01-1020) | Neuraxis | 2025-05-15 |
| K241533 | NeurAxis IB-Stim (01-1020) | Neuraxis | 2024-10-30 |
| K230526 | TEA Device | Transtimulation Research, Inc. | 2023-09-14 |
| DEN180057 | IB-Stim | Innovative Health Solutions (Ihs), Inc. | 2019-06-07 |