510(k) K162797
K162797 is an FDA 510(k) premarket notification submitted by Eneura, Inc. for the device "SpringTMS". The FDA issued a decision of Substantially Equivalent on Jun 26, 2017. The device falls under product code OKP (Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache), a Class II device regulated under 21 CFR 882.5808. Eneura, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 26, 2017
- Date Received
- Oct 4, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transcranial Magnetic Stimulator For The Treatment Of Migraine Headache
- Device Class
- Class II
- Regulation Number
- 882.5808
- Review Panel
- NE
- Submission Type
- 510(k)
Transcranial magnetic stimulator for the treatment of migraine headache delivers brief duration, rapidly alternating, or pulsed, magnetic fields that are externally directed at spatially discrete regions of the brain to induce electric currents for the treatment of migraine headache.