NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR
FDA 510(k) clearance DEN130022 · decided 2013-12-13
Clearance details
- K-number
- DEN130022
- Device name
- NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR
- Applicant
- Eneura Therapeutics
- Decision
- Unknown
- Date received
- 2013-03-05
- Decision date
- 2013-12-13
- Days to decision
- 283 days
- Clearance type
- Direct
- Product code
- OKP
- Device class
- 2
- Regulation number
- 882.5808
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Orono, MN, 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 |
|---|---|---|
| SAVI Dual (TM) Migraine Therapy (K230358) | Eneura, Inc. | 2023-05-16 |
| SpringTMS (K182976) | Eneura®, Inc. | 2019-02-25 |
| SpringTMS (K162797) | Eneura, Inc. | 2017-06-26 |
| sTMS mini (K161663) | Eneura, Inc. | 2016-08-23 |
| SPRINGTMS TOTAL MIGRAINE SYSTEM (K140094) | Eneura Therapeutics, LLC | 2014-05-21 |
Recalls involving this device
No recalls on record reference this clearance.