FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Encora X1
K Number: K251517
·
Decision Feb 5, 2026
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
8
Applicant Total
1
Review Days
265
Basic Information
- Device Name
- Encora X1
- K Number
- K251517
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5897
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Encora, Inc.
- Date Received
- May 16, 2025
- Decision Date
- February 5, 2026
- Product Code
- QBC
- 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 |
|---|---|---|---|
| QBC | External Upper Limb Tremor Stimulator | FDA class 2 | Neurology |
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