Data / Medical devices / United States / Soterix Medical,inc.

Soterix Medical,inc.: FDA-registered device maker in Woodbridge, NJ, United States, 3 510(k) clearances

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

Soterix Medical,inc. is registered with the FDA (registration 3012182497) in Woodbridge, NJ, United States. It lists 7 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 25, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3012182497
Address: 1480 US Highway 9 North, 204, Woodbridge, NJ, United States, 07095
Owner or operator: Soterix Medical,Inc. (10054978)
Roles: Manufacturer
First device listed: May 19, 2017
Registered through: 2026
Brand names listed: IontoDC, MEGA-IOM, MEGA-TMS

Devices it lists

Device	Product code	Class	Role	Source
Device, Iontophoresis, Other Uses	EGJ	2	Manufacturer	accessdata.fda.gov
Device, Nerve Conduction Velocity Measurement	JXE	2	Manufacturer	accessdata.fda.gov
Neurosurgical Nerve Locator	PDQ	2	Manufacturer	accessdata.fda.gov
Non-Normalizing Quantitative Electroencephalograph Software	OLT	2	Manufacturer	accessdata.fda.gov
Stimulator, Auditory, Evoked Response	GWJ	2	Manufacturer	accessdata.fda.gov
Stimulator, Electrical, Evoked Response	GWF	2	Manufacturer	accessdata.fda.gov
Stimulator, Photic, Evoked Response	GWE	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
March 25, 2024	K234080	MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)	GWF	Substantially Equivalent	Soterix Medical, Inc.	accessdata.fda.gov
August 13, 2021	K192823	MEGA-TMS	GWF	Substantially Equivalent	Soterix Medical, Inc.	accessdata.fda.gov
May 1, 2017	K170291	IontoDC	EGJ	Substantially Equivalent	Soterix Medical, Inc.	accessdata.fda.gov

Compare with other makers

Updated March 25, 2024. 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.