NeurAxis IB-Stim (01-1020)
FDA 510(k) clearance K241533 · decided 2024-10-30
Clearance details
- K-number
- K241533
- Device name
- NeurAxis IB-Stim (01-1020)
- Applicant
- Neuraxis
- Decision
- Substantially Equivalent
- Date received
- 2024-05-30
- Decision date
- 2024-10-30
- Days to decision
- 153 days
- Clearance type
- Traditional
- Product code
- QHH
- Device class
- 2
- Regulation number
- 876.5340
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Carmel, IN, 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 |
| TEA Device (K230526) | Transtimulation Research, Inc. | 2023-09-14 |
| 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.