FDA Product Code
FDA Product Code OKP — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Neurology
- 21 CFR Citation
- 882.5808
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K230358 | SAVI Dual (TM) Migraine Therapy | Eneura, Inc. | 2023-05-16 | Special | PDF ↗ |
| K182976 | SpringTMS | Eneura®, Inc. | 2019-02-25 | Traditional | PDF ↗ |
| K162797 | SpringTMS | Eneura, Inc. | 2017-06-26 | Traditional | PDF ↗ |
| K161663 | sTMS mini | Eneura, Inc. | 2016-08-23 | Special | PDF ↗ |
| K140094 | SPRINGTMS TOTAL MIGRAINE SYSTEM | Eneura Therapeutics, LLC | 2014-05-21 | Traditional | PDF ↗ |
| DEN130022 | NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR | Eneura Therapeutics | 2013-12-13 | Direct | — |
Product code OKP · Class II · Neurology. Data: openFDA.