NeuroStar Head Support System, Domestic

FDA UDI

Class II (US FDA UDI)

by Neuronetics Inc.

Identity

Trade Name: NeuroStar Head Support System, Domestic FDA UDI
Generic Name: Magnetic neural stimulation system FDA UDI
Device Name: The NeuroStar Head Support System can be adjusted to the patient's comfort and is used to aid in the process of determining and recording the coil locations during the motor threshold (MT) and treatment processes. FDA UDI
Model / Reference: 81-07836-000 FDA UDI
Description: The NeuroStar Head Support System can be adjusted to the patient's comfort and is used to aid in the process of determining and recording the coil locations during the motor threshold (MT) and treatment processes. FDA UDI

Identifiers

Primary DI / UDI-DI: 00850005944775 FDA UDI
510(k) Number: K161519 FDA UDI
FDA Product Code: OBP FDA UDI
GMDN Term: Magnetic neural stimulation system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.5805 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Magnetic neural stimulation system

NeuroStar Head Support System, Domestic by Neuronetics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K161519 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Neuronetics Inc.

Sources (1)

FDA UDI 29c31936-f943-4ceb-97e9-d2ddc22129a6 35 fields · synced Jun 8, 2026