What is FDA product code OBP?

A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder.

Neurology › TherapeuticTranscranial Magnetic Stimulator

Horizon 3.0 Mainframe

Name: Horizon 3.0 Mainframe
Brand: Horizon 3.0 Mainframe

Catalogue number 5800-00, listed by THE Magstim Company Ltd., United Kingdom, under Transcranial Magnetic Stimulator. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

3510(k) clearances naming this product code

4recalls on this code

Who Else Makes It

Concentrated in Guangdong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OBP
Manufacturer	City	Province	Registered as	Device types
Mastars Industries Co., Ltd.	Guangdong	Guangdong	Contract manufacturer	3
Yiwu Inwell Craft&Gift Co., Ltd.	Jin Hua	Zhejiang	Contract manufacturer	7
Shenzhen Yingchi Technology Co., Ltd.	Shenzhen	Guangdong	Manufacturer	3

Record

Regulatory record for Horizon 3.0 Mainframe
Listed by	THE Magstim Company Ltd., United Kingdom
FDA product code	OBP
Device type	Transcranial Magnetic Stimulator
Device class	Class 2
Regulation	21 CFR 882.5805
Establishment	Complaint-file establishment, Manufacturer
510(k)	K211389
Record published	2021-12-21

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Horizon 3.0 Mainframe
Catalogue number	Size	Status
5800-00		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
MagPro Accessories	Tonica Elektronik A/S	31
MagPro	Tonica Elektronik A/S	18
NeuroStar Advanced Therapy System	Neuronetics Inc.	15
Deep Transcranial Magnetic Stimulation (Dtms) System	Brainsway Ltd.	10
TrakStar Patient Data Management System Software	Neuronetics Inc.	5
NeuroStar System Software	Neuronetics Inc.	4
NeuroStar TMS Therapy System	Neuronetics Inc.	4
Ultimate rTMS	Shenzhen Yingzhi Technology Co., Ltd.	4
NeuroStar Head Support System, Domestic	Neuronetics Inc.	3
Saint	Magnus Medical Inc.	3
SenStar Treatment Link	Neuronetics Inc.	2
Ampa One System	Neuromodulatory Devices & Applications	2

Showing 12 of 98. All products under Transcranial Magnetic Stimulator

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K243869	2025-03-17
K241518	2024-08-30
K232235	2023-10-25

Recalls

4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2020-03-23	Class II	Nonconforming Material/Component	It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.	71 units total	2024-09-20
2020-03-23	Class II	Nonconforming Material/Component	It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail.	71 units total	2024-09-20
2018-10-25	Class II	Nonconforming Material/Component	A stray strand of stainless-steel cable may protrude from the heat shrink sleeving on the Balance Cable of the Ez Arm.	27 (including 2 demos)
2017-09-28	Class II	Employee error	Users manuals not supplied with 4800-00T US Rapid Therapy System	43	2022-06-21

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.