FDA.reportPublic FDA data

Jewel Mobile App

Primary DI
00850047782168
Brand
Jewel Mobile App
Company
Element Science, Inc.
Model
Jewel Mobile App
Catalog number
com.elementscience.jewel
Device description
Jewel Mobile Application (Android) Version 2.00.000
Published
2026-05-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MVKWearable Automated External Defibrillator

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MVKWearable Automated External DefibrillatorUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P230022003

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230022003Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin PreparatiElement Science, Inc.2025-04-30MVK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850047782168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047782168008500477821688500477821680850047782168

GMDN Terms#

Term, Definition table
TermDefinition
Wearable defibrillation system defibrillatorA portable, battery-powered defibrillator carried by a patient, typically in a shoulder bag, and connected to the body-worn electrodes within the vest of a wearable defibrillation system. It continuously monitors the patient's heart rhythms for the detection of life-threatening arrhythmias (ventricular fibrillation/pulseless ventricular tachycardia) and alerts the patient prior to electrical treatment shock delivery, allowing a conscious patient to disarm the treatment shock; should the patient be unconscious the defibrillator activates the electrodes (release of their gel) and delivers the shock to restore normal rhythm.

Regulatory Flags#

DUNS number
079801768
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850047782052Jewel Mobile AppJewel Mobile Appcom.elementscience.es-22026-05-04
00850047782007"Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (""Jewel"")"ES-2JWL1-MDU0-E-012025-05-12
00850047782038Jewel Starter KitES-2JWL1-STRT-K-012025-05-12
00850047782090Jewel PatchES-2JWL1-PTCH-K-012025-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850047782052Jewel Mobile AppElement Science, Inc.MVK2026-05-04
00840241600375ASSURE WCD SystemKestra Medical Technologies, Inc.MVK2026-04-15
00840241600405ASSURE, MonitorKestra Medical Technologies, Inc.MVK2026-04-15
00850047782007"Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (""Jewel"")"Element Science, Inc.MVK2025-05-12
00850047782038Jewel Starter KitElement Science, Inc.MVK2025-05-12
00850047782090Jewel PatchElement Science, Inc.MVK2025-05-12
00855778005432LifeVest Wearable DefibrillatorZOLL MANUFACTURING CORPORATIONMVK2024-08-21
00855778005449LifeVest Wearable DefibrillatorZOLL MANUFACTURING CORPORATIONMVK2024-08-21
00855778005371LifeVest Wearable DefibrillatorZOLL MANUFACTURING CORPORATIONMVK2024-08-19
00855778005388LifeVest Wearable DefibrillatorZOLL MANUFACTURING CORPORATIONMVK2024-08-19
00855778005395LifeVest Wearable DefibrillatorZOLL MANUFACTURING CORPORATIONMVK2024-08-19
00855778005401LifeVest Wearable DefibrillatorZOLL MANUFACTURING CORPORATIONMVK2024-08-19
00840241600238ASSURE WCD SystemKestra Medical Technologies, Inc.MVK2023-06-26
00840241600221ASSURE, MonitorKestra Medical Technologies, Inc.MVK2022-12-09
00840241600245ASSURE, TabletKestra Medical Technologies, Inc.MVK2022-12-09
00840241600009ASSURE, Battery Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600016ASSURE, ChargerKestra Medical Technologies, Inc.MVK2021-11-15
00840241600023ASSURE, Therapy CableKestra Medical Technologies, Inc.MVK2021-11-15
00840241600030ASSURE, MonitorKestra Medical Technologies, Inc.MVK2021-11-15
00840241600047ASSURE WCD SystemKestra Medical Technologies, Inc.MVK2021-11-15
00840241600054ASSURE, Garment, Style A, Size 1Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600061ASSURE, Garment, Style A, Size 2Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600078ASSURE, Garment, Style A, Size 3Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600085ASSURE, Garment, Style A, Size 4Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600092ASSURE, Garment, Style A, Size 5Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600108ASSURE, Garment, Style A, Size 6Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600115ASSURE, Garment, Style A, Size 7Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600122ASSURE, Garment, Style B, Size 1Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600139ASSURE, Garment, Style B, Size 2Kestra Medical Technologies, Inc.MVK2021-11-15
00840241600146ASSURE, Garment, Style B, Size 3Kestra Medical Technologies, Inc.MVK2021-11-15