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510(k) K251517

Encora X1 by Encora, Inc. — Product Code QBC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 2026
Date Received
May 16, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
External Upper Limb Tremor Stimulator
Device Class
Class II
Regulation Number
882.5897
Review Panel
NE
Submission Type

An external upper limb tremor stimulator is a prescription device which is placed externally on the upper limb and designed to aid in tremor symptom relief of the upper limb.

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