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Neuronetics Inc.

Last updated September 17, 2026

Information

Country: US
Address: 3222 Phoenixville Pike, Malvern, PA, 19355
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3004824012
DUNS Number: —

Catalogue (63)

Page 1 of 2

Device	Model / Reference	Registries	Class	Status
D-Tect MT Accessory	81-00241-000	FDA UDI	Class II	Active
NeuroStar TMS Therapy System	Upgrade Kit 3.0 US	FDA UDI	Class II	Active
NeuroStar Advanced Therapy System	2.X	FDA UDI	Class II	Active
NeuroStar Advanced Therapy System	Version 3.6	FDA UDI	Class II	Active
TrakStar Patient Data Management System Software	Version 7.6 (Cloud)	FDA UDI	Class II	Active
SenStar Treatment Link	81-70100-000	FDA UDI	Class II	Active
SenStar Connect Treatment Link	81-71100-100	FDA UDI	Class II	Active
NeuroStar System Software	Version 3.6	FDA UDI	Class II	Active
NeuroStar Advanced Therapy System	Version 3.6	FDA UDI	Class II	Active
Head Side Pad, 3 Pack	81-00848-000	FDA UDI	Class II	Active
NeuroStar Advanced Therapy System	Version 3.7	FDA UDI	Class II	Active
NeuroStar Head Support System, Domestic	81-07836-000	FDA UDI	Class II	Active
NeuroStar Advanced Therapy System	Version 3.7	FDA UDI	Class II	Active
NeuroStar Advanced Therapy System	Version 3.8	FDA UDI	Class II	Active
TrakStar Patient Data Management System Software	Version 7.7	FDA UDI	Class II	Active
Wedge Cushion, Gray	87-00022-100	FDA UDI	Class II	Active
Wedge Cushion, Blue	87-00022-000	FDA UDI	Class II	Active
TrakStar Patient Data Management System Software	Version 7.8 (Local)	FDA UDI	Class II	Active
NeuroStar Advanced Therapy System	2.X to 3.7 System Upgrade Kit	FDA UDI	Class II	Active
TrakStar Patient Data Management System Software	Version 7.6 (Local)	FDA UDI	Class II	Active
TrakStar Patient Data Management System Software	Version 7.5 (Cloud)	FDA UDI	Class II	Active
NeuroStar Advanced Therapy System	Version 3.8	FDA UDI	Class II	Active
Arm Support Cushion, Blue	87-00021-000	FDA UDI	Class II	Active
Treatment Pack, 50 Pack	81-00930-000	FDA UDI	Class II	Active
NeuroSITE	81-72024-000	FDA UDI	Class II	Active
NeuroStar Advanced Therapy System	3.X to 3.7 System Upgrade Kit (TouchStar Capable)	FDA UDI	Class II	Active
NeuroStar Advanced Therapy System	Version 3.8	FDA UDI	Class II	Active
NeuroStar Advanced Therapy System	Version 3.6	FDA UDI	Class II	Active
NeuroStar Advanced Therapy System	3.X	FDA UDI	Class II	Active
NeuroStar TMS Therapy System	NeuroStar 2.0 US	FDA UDI	Class II	Active
NeuroStar TMS Therapy System	Multi-Coil Option Upgrade	FDA UDI	Class II	Unknown
NeuroStar System Software	Version 3.8	FDA UDI	Class II	Active
MT Cap	85-01353-000	FDA UDI	Class II	Active
SenStar Connect Treatment Link	81-71000-100	FDA UDI	Class II	Active
NeuroStar TMS Therapy System	NeuroStar 3.0 US	FDA UDI	Class II	Active
Head Cushion Insert Set, Gray	87-00657-100	FDA UDI	Class II	Active
TrakStar Patient Data Management System Software	Version 7.8 (Cloud)	FDA UDI	Class II	Active
Head Cushion Insert Set, Blue	87-00657-000	FDA UDI	Class II	Active
NeuroStar Advanced Therapy System	3.X to 3.7 System Upgrade Kit (without TouchStar)	FDA UDI	Class II	Active
OCD MT Cap	85-00397-000	FDA UDI	Class II	Active
SenStar Treatment Link	81-70000-000	FDA UDI	Class II	Active
NeuroStar Advanced Therapy System	Version 3.X	FDA UDI	Class II	Active
NeuroStar Advanced Therapy System	Version 3.7	FDA UDI	Class II	Active
NeuroStar System Software	Version 3.7	FDA UDI	Class II	Active
TrakStar Patient Data Management System Software	Version 7.5 (Local)	FDA UDI	Class II	Active
NeuroStar System Software	Version 3.5	FDA UDI	Class II	Active
NeuroStar Headrest	81-72026-000	FDA UDI	Class II	Active
Arm Support Cushion, Gray	87-00021-100	FDA UDI	Class II	Active
NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar	K212289	FDA 510(k)	Class II	Active
Neurostar Tms Therapy System	K130233	FDA 510(k)	Class II	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Mar 16, 2009	Z-1421-2009	—	terminated	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.