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Horizon 3.0 Interface Unit

FDA UDI

Class II (US FDA UDI)

by The Magstim Company , Ltd.

Identity

Trade Name
Horizon 3.0 Interface Unit FDA UDI
Generic Name
Magnetic neural stimulation system FDA UDI
Model / Reference
5790-00 FDA UDI

Identifiers

Primary DI / UDI-DI
05060229532732 FDA UDI
510(k) Number
K211389 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

No

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Magnetic neural stimulation system

Horizon 3.0 Interface Unit by The Magstim Company , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Magnetic neural stimulation system.

Cleared under the same submission

K211389 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
The Magstim Company , Ltd.

Sources (1)

  • FDA UDI 8e1747d1-6b74-4de2-9ddf-4f4475105434 34 fields · synced Jun 6, 2026