EDGE LIFE TECHNOLOGIES, LLC

FDA Device Registration & Listing · Doral, FL, US · Registration 3034232408

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
3034232408
FEI Number
3034232408
Entity Name
EDGE LIFE TECHNOLOGIES, LLC
City/State/Country
Doral, FL, US
Establishment Address
8405 Nw 29th St, Doral, FL 33122, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Edge Life Technologies, LLC (Owner Number: 10092096)
Owner / Operator Contact Address
8405 NW 29th St, Doral, FL 33122, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K234153
PMA Number
N/A

All Registered Proprietary Names

EdgeLife Handheld Wireless Ultrasound System (E8200) EdgeLife Handheld Wireless Ultrasound System (E8220)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYN System, Imaging, Pulsed Doppler, Ultrasonic Radiology Class 2 892.1550 2024-12-03
IYO System, Imaging, Pulsed Echo, Ultrasonic Radiology Class 2 892.1560 2024-12-03
ITX Transducer, Ultrasonic, Diagnostic Radiology Class 2 892.1570 2024-12-03

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Edge Life Technologies, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K191007 Supersonic Imagine Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems 2019-10-25
K974588 Rimed , Ltd. INTRA-VIEW BILATERAL TRANSCRANIAL DOPPLER DEVICE, SMART-LITE PORTABLE BILATERAL TRANSCRANIAL DOPPLER DEVICE, COMPACT MOD 1998-08-07
K142628 Siemens Medi Cal Solutions, Inc. Acuson SC2000 Diagnostic Ultrasound System 2014-10-10
K132171 Supersonic Imagine AIXPLORER 2013-09-24
K222441 Bk Medical Aps Ultrasound System 2300 2022-12-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0189-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 750 Ultrasound Software Version: V1.0.0 through V2.1.3
Z-0190-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 850 Ultrasound- Software Version: V1.0.0 through V4.1.3
Z-0191-2022 FujiFilm Healthcare Americas Corporation 2
Lisendo 880 Ultrasound Software Version: V1.0 through V4.1.3
Z-0192-2022 FujiFilm Healthcare Americas Corporation 2
Arietta 65 Ultrasound Software Versions: V1.0 through V4.0.0
Z-1884-2024 FUJIFILM Healthcare Americas Corporation 2
Noblus AC Adapter used with the Noblus Ultrasound Imaging System Model : AHM250PS24

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3034232408. Last updated year: 2026. Please use registration number 3034232408 when referencing this establishment in official correspondence.
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