510(k) K161663
K161663 is an FDA 510(k) premarket notification submitted by Eneura, Inc. for the device "sTMS mini". The FDA issued a decision of Substantially Equivalent on August 23, 2016. 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 at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 2016
- Date Received
- June 16, 2016
- Clearance Type
- Special
- 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
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.