Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008881376

FEI Number

3008881376

Entity Name

TELEEMG, LLC

City/State/Country

E Falmouth, MA, US

Establishment Address

5 Flossmore Rd, E Falmouth, MA 02536, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

TeleEMG, LLC (Owner Number: 10035741)

Owner / Operator Contact Address

7304 Beverly Blvd #357, Los Angeles, CA 90036, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K160309

PMA Number

N/A

All Registered Proprietary Names

Neuron-Spectrum-4/P with Neuron-Spectrum.NET software CloudEEG Neuro-Audio Focus EMG CloudEMG CloudEKG FocusTMS Neurosoft TMS CloudTMS Cloud TMS Focus TMS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2019-07-29
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2019-07-29
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2019-07-29
GWJ	Stimulator, Auditory, Evoked Response	Neurology	Class 2	882.1900	2015-12-10
EWO	Audiometer	Ear, Nose, Throat	Class 2	874.1050	2015-12-10
IKN	Electromyograph, Diagnostic	Physical Medicine	Class 2	890.1375	2015-09-21
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	Class 2	882.1550	2015-09-21
DXH	Transmitters And Receivers, Electrocardiograph, Telephone	Cardiovascular	Class 2	870.2920	2015-12-10
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2016-12-28

Official Correspondent

Joe Jabre

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TeleEMG, 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
K033010	Brainz Instruments , Ltd.	BRM2 BRAIN MONITOR	2003-10-10
K991012	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY EEG POD	1999-06-24
K852587	Tracor Northern, Inc.	CDSA(COLOR DENSITY, SPECTRAL ARRRAY)	1985-08-16
K161650	Neurotronics, Inc.	Polysmith Sleep System, Model NTI7593	2017-01-19
K780270	Maico Hearing Instruments, Inc.	COMPUTER AUDIOMETER - MA26	1978-02-27

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008881376. Last updated year: 2026. Please use registration number 3008881376 when referencing this establishment in official correspondence.