Data / Medical devices / United States / Element Science, Inc.
Element Science, Inc.: FDA-registered device maker in Redwood City, CA, United States, 1 PMA approval
Element Science, Inc. is registered with the FDA (registration 3027605722) in Redwood City, CA, United States. It lists 2 device types. The FDA files 1 PMA approval under its listings, the newest dated April 30, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027605722
- Address
- 301 Chesapeake Dr, Redwood City, CA, United States, 94063
- Owner or operator
- Element Science, Inc. (10093342)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- May 2, 2025
- Registered through
- 2026
- Brand names listed
- Element Science Clinical Portal, Jewel® Patch Wearable Cardioverter Defibrillator ("Jewel")
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Wearable Automated External Defibrillator | MVK | 3 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| April 30, 2025 | P230022 | Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel), Jewel P-WCD Firmware, Device Accessories Skin Preparati | MVK | 5 | March 4, 2026 | accessdata.fda.gov |
Compare with other makers
Updated March 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.