SOTERIX MEDICAL,INC.

FDA Device Registration & Listing · Woodbridge, NJ, US · Registration 3012182497

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012182497
FEI Number
3012182497
Entity Name
SOTERIX MEDICAL,INC.
City/State/Country
Woodbridge, NJ, US
Establishment Address
1480 US Highway 9 North, 204, Woodbridge, NJ 07095, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Soterix Medical,Inc. (Owner Number: 10054978)
Owner / Operator Contact Address
1480 US Highway 9 North, 204, Woodbridge, NJ 07095, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K170291
PMA Number
N/A

All Registered Proprietary Names

MEGA-TMS MEGA-IOM IontoDC

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JXE Device, Nerve Conduction Velocity Measurement Neurology Class 2 882.1550 2023-12-01
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2023-12-01
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2024-06-13
GWJ Stimulator, Auditory, Evoked Response Neurology Class 2 882.1900 2024-06-13
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2024-06-13
GWE Stimulator, Photic, Evoked Response Neurology Class 2 882.1890 2024-06-13
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2024-06-13
EGJ Device, Iontophoresis, Other Uses Physical Medicine Class 2 890.5525 2017-05-19

Official Correspondent

Abhishek Datta

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Soterix Medical,Inc.
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
K880088 Cadwell Laboratories, Inc. CADWELL EXCEL 1988-05-04
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
K842483 Santa Barbara Medco, Inc. SANTA BARBARA MEDCO-LANTOPHORETIC APPLIC 1984-08-31

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012182497. Last updated year: 2026. Please use registration number 3012182497 when referencing this establishment in official correspondence.
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