FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Nerivio; Nerivio Infinity
K Number: K250405
·
Decision May 14, 2025
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
6
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- Nerivio; Nerivio Infinity
- K Number
- K250405
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5899
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Theranica Bio-Electronics, Ltd.
- Date Received
- February 13, 2025
- Decision Date
- May 14, 2025
- Product Code
- QGT
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QGT | Distal Transcutaneous Electrical Stimulator For Treatment Of Acute Migraine | FDA class 2 | Neurology |
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