Neuronetics Inc.
Malvern, PA, US
Neuronetics Inc. appears in FDA device records in Malvern, PA. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Neuronetics Inc. between 2008 and 2024. The busiest year on record is 2022, with 3. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2016 | 2 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 3 |
| 2023 | 3 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231926 | NeuroStar Advanced Therapy System (All previously cleared models) | OBP | Substantially Equivalent | |
| K233621 | NeuroStar Advanced Therapy System (Version 3.8) | OBP | Substantially Equivalent | |
| K231350 | OCD MT Cap (85-00397-000) | QCI | Substantially Equivalent | |
| K230029 | NeuroStar Advanced Therapy System (Version 3.7) | OBP | Substantially Equivalent | |
| K222230 | NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health | OBP | Substantially Equivalent | |
| K220127 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health | OBP | Substantially Equivalent | |
| 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 | |
| K213543 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health | OBP | Substantially Equivalent | |
| K201158 | NeuroStar Advanced Therapy | OBP | Substantially Equivalent | |
| K161519 | NeuroStar TMS Therapy System | OBP | Substantially Equivalent | |
| K160703 | NeuroStar TMS Therapy System | OBP | Substantially Equivalent | |
| K133408 | NEUROSTAR TMS THERAPY SYSTEM | OBP | Substantially Equivalent | |
| K130233 | NEUROSTAR TMS THERAPY SYSTEM | OBP | Substantially Equivalent | |
| K083538 | NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 | OBP | Substantially Equivalent | |
| DEN070003 | NEUROSTAR TMS SYSTEM | OBP | Unknown |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004824012 | 3004824012 | Neuronetics Inc. | 3222 Phoenixville Pike, Malvern, PA 19355 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1421-2009 | 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 magnetic fields to stimulate function in targeted brain regions. | 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. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain