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

SenStar Connect Treatment Link

Name: SenStar Connect Treatment Link
Brand: SenStar Connect Treatment Link

Catalogue number 81-71000-100, listed by Neuronetics Inc., United States, under Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder. 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

2510(k) clearances naming this product 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 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 SenStar Connect Treatment Link
Listed by	Neuronetics Inc., United States
FDA product code	QCI
Device type	Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder
Device class	Class 2
Regulation	21 CFR 882.5802
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K161519
Record published	2022-10-05

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Packaging	Inner pack of 5

Catalogue Numbers

Catalogue numbers for SenStar Connect Treatment Link
Catalogue number	Size	Status
81-71000-100		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
MagPro Accessories	Tonica Elektronik A/S	5
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
NeuroSITE	Neuronetics Inc.	1
OCD MT Cap	Neuronetics Inc.	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K231350	2023-06-08
K212289	2022-05-06

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.