510(k) K250405
K250405 is an FDA 510(k) premarket notification submitted by Theranica Bio-Electronics, Ltd. for the device "Nerivio; Nerivio Infinity". The FDA issued a decision of Substantially Equivalent on May 14, 2025. The device falls under product code QGT (Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine), a Class II device regulated under 21 CFR 882.5899. Theranica Bio-Electronics, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 2025
- Date Received
- February 13, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine
- Device Class
- Class II
- Regulation Number
- 882.5899
- Review Panel
- NE
- Submission Type
A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.