The following data is part of a premarket notification filed by Eneura Therapeutics, Llc with the FDA for Springtms Total Migraine System.
| Device ID | K140094 |
| 510k Number | K140094 |
| Device Name: | SPRINGTMS TOTAL MIGRAINE SYSTEM |
| Classification | Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache |
| Applicant | ENEURA THERAPEUTICS, LLC 2690 PHEASANT ROAD Orono, MN 55331 |
| Contact | Larry Getlin |
| Correspondent | Larry Getlin ENEURA THERAPEUTICS, LLC 2690 PHEASANT ROAD Orono, MN 55331 |
| Product Code | OKP |
| CFR Regulation Number | 882.5808 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-14 |
| Decision Date | 2014-05-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816140020101 | K140094 | 000 |
| 00816140020040 | K140094 | 000 |
| 00816140020019 | K140094 | 000 |
| 00816140020002 | K140094 | 000 |