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MT Cap

FDA UDI

Class II (US FDA UDI)

by Neuronetics Inc.

Identity

Trade Name
MT Cap FDA UDI
Generic Name
Magnetic neural stimulation system FDA UDI
Device Name
The MT Cap is used to aid in the motor threshold (MT) determination process. FDA UDI
Model / Reference
85-01353-000 FDA UDI
Description
The MT Cap is used to aid in the motor threshold (MT) determination process. FDA UDI

Identifiers

Primary DI / UDI-DI
00850005944379 FDA UDI
510(k) Number
K213543 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Magnetic neural stimulation system

MT Cap by Neuronetics Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Magnetic neural stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Neuronetics Inc.

Sources (1)

  • FDA UDI ae204c98-9e93-40c8-b420-ead13af140df 35 fields · synced May 30, 2026