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Encora X1 Stimulator STIM-001

by Encora, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00860014353031 UDI-DI Date11 Aug 2026ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
Encora X1 Stimulator
Generic Name
Tremor-suppression transcutaneous electrical stimulation wristband
Model / Reference
STIM-001
Primary DI / UDI-DI
00860014353031
510(k) Number
FDA Product Code
QBC
GMDN Term
Tremor-suppression transcutaneous electrical stimulation wristband
Device Class
Class II
Regulation Number
882.5897
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K251517)

Other devices from Encora, Inc.

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No