Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030151584

FEI Number

3030151584

Entity Name

IMEX, LLC

City/State/Country

Fulton, MD, US

Establishment Address

11820 West Market Place, Suite K, Fulton, MD 20759, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Imex, LLC (Owner Number: 10089504)

Owner / Operator Contact Address

11820 West Market Place, Suite K, Fulton, MD 20759, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K942441

PMA Number

N/A

All Registered Proprietary Names

Dynatronics Body Ice Cold Pack Elite 200 Elite 100R Elite 200R Elite 100 Pocket Dop II Dynatron Tri-Wave Light Probe DCP3 Dynatron Tri-Wave Light Pad DLP3 Dynatron ThermoStim TM Probe DTSP1 Dynatron 125B CT+

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2026-05-06
JAF	Monitor, Ultrasonic, Nonfetal	Radiology	Class 2	892.1540	2023-12-13
KNG	Monitor, Ultrasonic, Fetal	Obstetrics/Gynecology	Class 2	884.2660	2023-12-13
ILY	Lamp, Infrared, Therapeutic Heating	Physical Medicine	Class 2	890.5500	2026-05-06
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2026-05-06
ILO	Pack, Hot Or Cold, Water Circulating	Physical Medicine	Class 2	890.5720	2026-05-06
IMI	Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat	Physical Medicine	Class 2	890.5300	2026-05-06
JAF	Monitor, Ultrasonic, Nonfetal	Radiology	Class 2	892.1540	2024-07-16

Official Correspondent

Bob Patterson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Imex, 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
K010521	Nicolet Biomedical	NICOLET VERSALAB	2001-03-09
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24
K073532	Technomed Europe	DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES	2008-05-01
K260363	Ceribell, Inc.	Ceribell Brain Monitor Headband	2026-04-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030151584. Last updated year: 2026. Please use registration number 3030151584 when referencing this establishment in official correspondence.