Data / Medical devices / United States / Imex, LLC

Imex, LLC: FDA-registered device maker in Fulton, MD, United States, 7 510(k) clearances

Name: Imex, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Imex, LLC is registered with the FDA (registration 3030151584) in Fulton, MD, United States. It lists 10 device types. The FDA files 7 510(k) clearances under its listings, the newest dated January 24, 2014. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3030151584
Address: 11820 West Market Place Suite K, Fulton, MD, United States, 20759
Owner or operator: Imex, LLC (10089504)
Roles: Manufacturer, Specification developer
First device listed: December 13, 2023
Registered through: 2026
Brand names listed: CT+, Dynatron 125B, Dynatron Plus 625, Dynatron Plus 925, Dynatron Solaris Plus 706, Dynatron Solaris Plus 709, Dynatron Solaris Plus Ultrasound Probe WSH05, Dynatron ThermoStim TM Probe DTSP1 and more

Devices it lists

Device	Product code	Class	Role	Source
Electrode, Cutaneous	GXY	2	Manufacturer	accessdata.fda.gov
Interferential Current Therapy	LIH	2	Manufacturer	accessdata.fda.gov
Lamp, Infrared, Therapeutic Heating	ILY	2	Manufacturer	accessdata.fda.gov
Monitor, Ultrasonic, Fetal	KNG	2	Manufacturer	accessdata.fda.gov
Monitor, Ultrasonic, Nonfetal	JAF	2	Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Specification developer	accessdata.fda.gov
Pack, Hot Or Cold, Water Circulating	ILO	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Manufacturer	accessdata.fda.gov
Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	IMI	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
January 24, 2014	K132057	DYNATRON PELTIER THERMOSTIM PROBE	GXY	Substantially Equivalent	Dynatronics Corp.	accessdata.fda.gov
February 9, 2012	K113250	DYNATRON TRI-WAVE LIGHT PAD DYNATRON TRI-WAVE LIGHT PROBE	ILY	Substantially Equivalent	Dynatronics Corp.	accessdata.fda.gov
October 22, 2003	K031329	DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)	IMI	Substantially Equivalent	Dynatronics Corp.	accessdata.fda.gov
August 7, 1998	K982635	CAREDOP II	JAF	Substantially Equivalent	Nicolet Biomedical	accessdata.fda.gov
August 26, 1996	K961250	DYNATRON 125 ULTRASOUND	IMI	Substantially Equivalent	Dynatronics Corp.	accessdata.fda.gov
August 23, 1994	K942441	IMEXDOP CT+	JAF	Substantially Equivalent	Imex Medical Systems, Inc.	accessdata.fda.gov
July 2, 1990	K901593	IMEX DOP-TONE II	KNG	Substantially Equivalent	Imex Medical Systems, Inc.	accessdata.fda.gov

Compare with other makers

Updated January 24, 2014. 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.