Encora X1— 510(k) K251517
Substantially EquivalentEncora, Inc.
FDA 510(k) clearance K251517 for Encora X1, Substantially Equivalent on 2026-02-05. Applicant: Encora, Inc.. Device class: 2.
Summary
Encora's Encora X1 is filed under product code QBC, external upper limb tremor stimulator. The record doesn't describe the device beyond its name and that code name.
Class II, 21 CFR 882.5897. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Encora filed from Boston, Massachusetts. The decision came 265 calendar days after FDA received it (May 16, 2025 to February 5, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Encora, Inc.
- Product code
- Product code QBC
- Device class
- Class 2
- Regulation
- 21 CFR 882.5897
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boston, MA, US
Recent devices under product code QBC
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