What is FDA product code QCI?

External device that uses magnetic fields to induce neural activity in the cerebral cortex to treat neurological and psychiatric disorders and conditions. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum).

Neurology › TherapeuticTranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder

MagPro Accessories

Name: MagPro Accessories
Brand: MagPro Accessories

Flow Arm coil adapter kit for A/P coils, ø38-1pcs. Approved with Flow Arm (9016B0801).

Registry build 21.09.26

3manufacturers in China registered for this device type

5catalogue numbers in this listing

1510(k) clearance

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 QCI
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 MagPro Accessories
Listed by	Tonica Elektronik A/S, Denmark
FDA product code	QCI
Device type	Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Device class	Class 2
Regulation	21 CFR 882.5802
Establishment	Contract manufacturer, Manufacturer
510(k)	K061645
Record published	2022-11-28

Specifications

Specifications
MRI safety	MR Unsafe
Prescription	Prescription only
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for MagPro Accessories
Catalogue number	Size	Status
Flow Arm coil adapter kit for A/P coils, ø38-1pcs		In distribution
Flow Arm		In distribution
Holder for MCF- and Cool Coils		In distribution
Flow Am coil adapter kit, ø29-2pcs		In distribution
Flow Arm Coil adapter kit, ø38-2pcs		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Deep Transcranial Magnetic Stimulation (Dtms) System	Brainsway Ltd.	6
CloudTMS for OCD	Neurosoft, OOO	3
TrakStar Patient Data Management System Software	Neuronetics Inc.	2
CloudTMS Edge for OCD	Neurosoft, OOO	2
NeuroStar Headrest	Neuronetics Inc.	2
CoudTMS Edge for OCD	Neurosoft, OOO	1
SenStar Connect Treatment Link	Neuronetics Inc.	1
NeuroSITE	Neuronetics Inc.	1
OCD MT Cap	Neuronetics Inc.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K193006	2020-08-09

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.