The following data is part of a premarket notification filed by Eneura® Inc. with the FDA for Springtms.
| Device ID | K182976 |
| 510k Number | K182976 |
| Device Name: | SpringTMS |
| Classification | Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache |
| Applicant | eNeura® Inc. 715 North Pastoria Avenue Sunnyvale, CA 94085 |
| Contact | David Rosen |
| Correspondent | Larry W. Getlin Larry W. Getlin 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 | 2018-10-26 |
| Decision Date | 2019-02-25 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SPRINGTMS 85035243 4010226 Live/Registered |
ENEURA, INC. 2010-05-11 |