Data / Medical devices / United States / Edge Life Technologies, LLC
Edge Life Technologies, LLC: FDA-registered device maker in Doral, FL, United States, 1 510(k) clearance
Edge Life Technologies, LLC is registered with the FDA (registration 3034232408) in Doral, FL, United States. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 18, 2024. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3034232408
- Address
- 8405 Nw 29th St, Doral, FL, United States, 33122
- Owner or operator
- Edge Life Technologies, LLC (10092096)
- Roles
- Manufacturer
- First device listed
- December 3, 2024
- Registered through
- 2026
- Brand names listed
- EdgeLife Handheld Wireless Ultrasound System (E8200), EdgeLife Handheld Wireless Ultrasound System (E8220)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 2 | Manufacturer | accessdata.fda.gov |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 2 | Manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 18, 2024 | K234153 | EdgeLife Handheld Wireless Ultrasound System (E8200); EdgeLife Handheld Wireless Ultrasound System (E8220) | IYN | Substantially Equivalent | Edgelife Technologies, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
- All makers of System, Imaging, Pulsed Doppler, Ultrasonic
- All makers of Transducer, Ultrasonic, Diagnostic
Updated September 18, 2024. 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.