510(k) K140094
- Device
- SPRINGTMS TOTAL MIGRAINE SYSTEM
- Applicant
- ENEURA THERAPEUTICS, LLC
- 510(k) number
- K140094
- Product code
- OKP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-05-21
- Date received
- 2014-01-14
- Regulation
- 882.5808
- Classification name
- Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LARRY GETLIN
- Address
- 2690 Pheasant Rd. Orono MN US 55331 55331
FDA Registration Numbers#
- 3008487930
- 3015259858
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code OKP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K230358 | SAVI Dual (TM) Migraine Therapy | Eneura, Inc. | 2023-05-16 |
| K182976 | SpringTMS | Eneura®, Inc. | 2019-02-25 |
| K162797 | SpringTMS | Eneura, Inc. | 2017-06-26 |
| K161663 | sTMS mini | Eneura, Inc. | 2016-08-23 |
| DEN130022 | NEURALIEVE CERENA TRANSCRANIAL MAGNETIC STIMULATOR | Eneura Therapeutics | 2013-12-13 |
Legacy Summary#
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FDA Review#
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