Data / Medical devices / United States / Teleemg, LLC

Teleemg, LLC: FDA-registered device maker in E Falmouth, MA, United States, 5 510(k) clearances

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

Teleemg, LLC is registered with the FDA (registration 3008881376) in E Falmouth, MA, United States. It lists 9 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 22, 2016. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3008881376
Address: 5 Flossmore Rd, E Falmouth, MA, United States, 02536
Owner or operator: TeleEMG, LLC (10035741)
Roles: Complaint file establishment
First device listed: September 21, 2015
Registered through: 2026
Brand names listed: Cloud TMS, CloudEEG, CloudEKG, CloudEMG, CloudTMS, Focus EMG, Focus TMS, FocusTMS and more

Devices it lists

Device	Product code	Class	Role	Source
Audiometer	EWO	2	Complaint file establishment	accessdata.fda.gov
Device, Nerve Conduction Velocity Measurement	JXE	2	Complaint file establishment	accessdata.fda.gov
Electromyograph, Diagnostic	IKN	2	Complaint file establishment	accessdata.fda.gov
Full-Montage Standard Electroencephalograph	GWQ	2	Complaint file establishment	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Complaint file establishment	accessdata.fda.gov
Standard Polysomnograph With Electroencephalograph	OLV	2	Complaint file establishment	accessdata.fda.gov
Stimulator, Auditory, Evoked Response	GWJ	2	Complaint file establishment	accessdata.fda.gov
Transcranial Magnetic Stimulator	OBP	2	Complaint file establishment	accessdata.fda.gov
Transmitters And Receivers, Electrocardiograph, Telephone	DXH	2	Complaint file establishment	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
December 22, 2016	K160309	Neurosoft TMS	OBP	Substantially Equivalent	Teleemg, LLC	accessdata.fda.gov
June 19, 2015	K133995	NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE	OLT	Substantially Equivalent	Neurosoft , Ltd.	accessdata.fda.gov
March 12, 2015	K141524	NEURO-AUDIO	EWO	Substantially Equivalent	Teleemg, LLC USA	accessdata.fda.gov
April 4, 2014	K130878	CLOUDEKG	DXH	Substantially Equivalent	Makromed, Inc.	accessdata.fda.gov
March 4, 2011	K102610	FOCUS EMG DEVICE	IKN	Substantially Equivalent	Teleemg, LLC USA	accessdata.fda.gov

Compare with other makers

Updated December 22, 2016. 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.