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Encora X1

by Encora, Inc.

510(k) K251517

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK251517 Date5 Feb 2026ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QBC
Device Class
Class II
Regulation
21 CFR Part 882.5897
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Encora X1 is an external upper limb tremor stimulator designed to manage tremors in the upper limbs. It is classified as a Class II medical device and is intended for use in neurology applications.

The device is supplied sterile and is intended for single use. It is MRI safe and available in multiple sizes. The Encora X1 is authorized under FDA 510(k) clearance (K251517) and is manufactured by Encora, Inc. in Boston, MA.

Other devices from Encora, Inc.

Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Encora X1 used for?

    The Encora X1 is an external upper limb tremor stimulator designed to manage tremors in the upper limbs. It is intended for use in neurology applications.

  • Is the Encora X1 intended for single use?

    Yes, the Encora X1 is intended for single use. It is supplied sterile and is not designed for reuse.

  • Is the Encora X1 safe for use in an MRI environment?

    Yes, the Encora X1 is MRI safe, allowing for use in environments with magnetic resonance imaging equipment.

  • What sizes is the Encora X1 available in?

    The Encora X1 is available in multiple sizes to accommodate different patient needs.

  • How was the Encora X1 authorized for sale?

    The Encora X1 is authorized under FDA 510(k) clearance (K251517) and is manufactured by Encora, Inc. in Boston, MA.