Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004824012

FEI Number

3004824012

Entity Name

Neuronetics Inc.

City/State/Country

Malvern, PA, US

Establishment Address

3222 Phoenixville Pike, Malvern, PA 19355, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Neuronetics Inc (Owner Number: 10027686)

Owner / Operator Contact Address

3222 Phoenixville Pike, Malvern, PA 19355, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222230

PMA Number

N/A

All Registered Proprietary Names

NeuroStar TMS Therapy System NeuroStar Advanced Therapy NeuroStar TMS Therapy System NeuroStar Advanced Therapy System Head Side Pad SenStar Connect Treatment Link Wedge Cushion NeuroStar System Software SenStar Treatment Link Head Insert Cushion Arm Support Cushion NeuroStar TMS Therapy System NeuroStar TMS Therapy System Laser Positioning Aid NeuroStar Advanced Therapy NeuroStar TMS Therapy System SenStar Connect Treatment Link NeuroStar Head Support System MT Cap NeuroStar TMS Therapy System Head Insert Cushion SenStar Treatment Link Head Side Pad Wedge Cushion Arm Support Cushion D-Tect MT Accessory

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2017-07-25
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2017-07-25
QCI	Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder	Neurology	Class 2	882.5802	2022-09-27
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2017-07-25
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2017-07-25
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2017-07-25
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2021-12-15
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2008-11-24
OBP	Transcranial Magnetic Stimulator	Neurology	Class 2	882.5805	2022-09-01

Official Correspondent

Alexandra Williamson

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Neuronetics 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
K243700	Mag & More GmbH	Apollo TMS Therapy System	2025-09-04
K231926	Neuronetics, Inc.	NeuroStar Advanced Therapy System (All previously cleared models)	2024-03-22

Similar Registrations

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3007147067	NEXSTIM PLC	Helsinki Uusimaa, FI
3003144120	SPARTRONICS STRONGSVILLE, INC.	Strongsville, OH, US
8021774	THE MAGSTIM COMPANY LTD.	Carmarthenshire Wales, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004824012. Last updated year: 2026. Please use registration number 3004824012 when referencing this establishment in official correspondence.