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Jewel Mobile App

by Element Science Inc. 2 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number00850047782052 UDI-DIDate4 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Wearable defibrillation system defibrillator
Model / Ref / Catalog
Jewel Mobile App, com.elementscience.es-2
Primary DI / UDI-DI
00850047782052
PMA Number
FDA Product Code
MVK
GMDN Term
Wearable defibrillation system defibrillator
Device Class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (P230022)

Other devices from Element Science Inc.

Properties

  • Prescription Use

Other properties (13)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No