ELEMENT SCIENCE, INC.

FDA Device Registration & Listing · Redwood City, CA, US · Registration 3027605722

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3027605722
FEI Number
3027605722
Entity Name
ELEMENT SCIENCE, INC.
City/State/Country
Redwood City, CA, US
Establishment Address
301 Chesapeake Dr, Redwood City, CA 94063, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
Element Science, Inc. (Owner Number: 10093342)
Owner / Operator Contact Address
301 Chesapeake Drive, Redwood City, CA 94063, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P230022

All Registered Proprietary Names

Element Science Clinical Portal Jewel® Patch Wearable Cardioverter Defibrillator ("Jewel")

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OUG Medical Device Data System General Hospital Class 1 880.6310 2025-05-02
MVK Wearable Automated External Defibrillator Unknown Class 3 N/A 2025-05-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Element Science, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027605722. Last updated year: 2026. Please use registration number 3027605722 when referencing this establishment in official correspondence.
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