FDA 510(k)
FDA class 2
Substantially Equivalent
🇧🇪 Belgium
CEFALY Connected - OTC, CEFALY Connected - Rx
K Number: K234029
·
Decision Jul 18, 2024
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
17
Applicant Total
6
Review Days
211
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Basic Information
- Device Name
- CEFALY Connected - OTC, CEFALY Connected - Rx
- K Number
- K234029
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5891
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cefaly Technology
- Date Received
- December 20, 2023
- Decision Date
- July 18, 2024
- Product Code
- PCC
- 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 |
|---|---|---|---|
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | FDA class 2 | Neurology |
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Other Clearances by Cefaly Technology
| K Number | Device Name | ||
|---|---|---|---|
| K212071 | Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx | Dec 13, 2022 | Substantially Equivalent |
| K201895 | Cefaly Dual | Sep 29, 2020 | Substantially Equivalent |
| K173006 | Cefaly Dual | Nov 28, 2017 | Substantially Equivalent |
| K171446 | Cefaly Acute | Sep 15, 2017 | Substantially Equivalent |
| K160237 | Cefaly | Mar 4, 2016 | Substantially Equivalent |