TEA Device
FDA 510(k) clearance K230526 · decided 2023-09-14
Clearance details
- K-number
- K230526
- Device name
- TEA Device
- Applicant
- Transtimulation Research, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-02-27
- Decision date
- 2023-09-14
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- QHH
- Device class
- 2
- Regulation number
- 876.5340
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Oklahoma City, OK, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NeurAxis IB-Stim (01-1020) (K252024) | Neuraxis | 2025-10-16 |
| NeurAxis IB-Stim (01-1020) (K250451) | Neuraxis | 2025-05-15 |
| NeurAxis IB-Stim (01-1020) (K241533) | Neuraxis | 2024-10-30 |
| First Relief v1 (K202940) | Dyansys, Inc. | 2020-12-29 |
| IB-Stim (DEN180057) | Innovative Health Solutions (Ihs), Inc. | 2019-06-07 |
Recalls involving this device
No recalls on record reference this clearance.