Data / Medical devices / United States / Neuronetics Inc.
Neuronetics Inc.: FDA-registered device maker in Malvern, PA, United States, 12 510(k) clearances
Neuronetics Inc. is registered with the FDA (registration 3004824012) in Malvern, PA, United States. It lists 2 device types. The FDA files 12 510(k) clearances under its listings, the newest dated March 22, 2024. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004824012
- Address
- 3222 Phoenixville Pike, Malvern, PA, United States, 19355
- Owner or operator
- Neuronetics Inc (10027686)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 24, 2008
- Registered through
- 2026
- Brand names listed
- Arm Support Cushion, D-Tect MT Accessory, Head Insert Cushion, Head Side Pad, MT Cap, NeuroSITE, NeuroStar Advanced Therapy, NeuroStar Advanced Therapy System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | QCI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Transcranial Magnetic Stimulator | OBP | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 22, 2024 | K231926 | NeuroStar Advanced Therapy System (All previously cleared models) | OBP | Substantially Equivalent | Neuronetics, Inc. | accessdata.fda.gov |
| December 13, 2023 | K233621 | NeuroStar Advanced Therapy System (Version 3.8) | OBP | Substantially Equivalent | Neuronetics | accessdata.fda.gov |
| June 8, 2023 | K231350 | OCD MT Cap (85-00397-000) | QCI | Substantially Equivalent | Neuronetics | accessdata.fda.gov |
| April 4, 2023 | K230029 | NeuroStar Advanced Therapy System (Version 3.7) | OBP | Substantially Equivalent | Neuronetics | accessdata.fda.gov |
| August 24, 2022 | K222230 | NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health | OBP | Substantially Equivalent | Neuronetics, Inc. | accessdata.fda.gov |
| May 6, 2022 | K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar | QCI | Substantially Equivalent | Neuronetics, Inc. | accessdata.fda.gov |
| December 10, 2021 | K213543 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health | OBP | Substantially Equivalent | Neuronetics, Inc. | accessdata.fda.gov |
| November 20, 2020 | K201158 | NeuroStar Advanced Therapy | OBP | Substantially Equivalent | Neuronetics, Inc. | accessdata.fda.gov |
| September 11, 2016 | K161519 | NeuroStar TMS Therapy System | OBP | Substantially Equivalent | Neuronetics, Inc. | accessdata.fda.gov |
| June 10, 2016 | K160703 | NeuroStar TMS Therapy System | OBP | Substantially Equivalent | Neuronetics, Inc. | accessdata.fda.gov |
| December 16, 2008 | K083538 | NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 | OBP | Substantially Equivalent | Neuronetics | accessdata.fda.gov |
| October 7, 2008 | DEN070003 | NEUROSTAR TMS SYSTEM | OBP | Unknown | Neuronetics | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 24, 2026 | 99812 | Class II | Ongoing | NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number 81-01000-200. Affects the below NeuroStar Advanced Therapy Systems: 1. NeuroStar 2.0 US; Part Number: 81-01315-000. 2. NeuroStar 3.0 | Cables are not in conformance with the product specifications required in the production of the HP Coil Assembly. | accessdata.fda.gov |
| March 16, 2009 | 51703 | Not yet classified | Terminated | NeuroStar TMS Therapy System/SenStar Treatment Link. The SenStar Treatment Link is a single use, disposable component of the NeuroStar TMS system, a non-invasive treatment for depression using highly focused, pulsed magn | SenStar Treatment Link may have an open circuit that during use with the NeuroStar TMS Therapy system may cause arcing and heat damage to the SenStar and/or treatment coil. Heating of the SenStar during use has a potential risk of minor scalp burn to patients. | accessdata.fda.gov |
Compare with other makers
- All makers of Transcranial Magnetic Stimulator
- All makers of Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Updated October 9, 2026. 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.