FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Aura Glide (FC40)
K Number: K252187
·
Decision Dec 23, 2025
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
77
Applicant Total
1
Review Days
162
Basic Information
- Device Name
- Aura Glide (FC40)
- K Number
- K252187
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Aura Medical, LLC
- Date Received
- July 14, 2025
- Decision Date
- December 23, 2025
- Product Code
- NFO
- 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 |
|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | FDA class 2 | Neurology |
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