FDA.reportPublic FDA data

"Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (""Jewel"")"

Primary DI
00850047782007
Brand
"Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (""Jewel"")"
Company
Element Science, Inc.
Model
ES-2
Catalog number
JWL1-MDU0-E-01
Device description
ES-2 Reusable Defibrillator Unit, Packaged (900-00032)
Published
2025-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
P230022000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P230022000Jewel 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
00850047782007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047782007008500477820078500477820070850047782007

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079801768
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850047782052Jewel Mobile AppJewel Mobile Appcom.elementscience.es-22026-05-04
00850047782168Jewel Mobile AppJewel Mobile Appcom.elementscience.jewel2026-05-04
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
00850047782168Jewel Mobile AppElement Science, Inc.MVK2026-05-04
00840241600375ASSURE WCD SystemKestra Medical Technologies, Inc.MVK2026-04-15
00840241600405ASSURE, MonitorKestra Medical Technologies, Inc.MVK2026-04-15
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