OCD MT Cap
OCD MT Cap is a single-use wearable guide for the motor threshold determination process with the NeuroStar Advanced Therapy System. A clinician uses it to help locate the individual…
OCD MT Cap is a single-use wearable guide for the motor threshold determination process with the NeuroStar Advanced Therapy System. A clinician uses it to help locate the individual patient’s motor threshold site before treatment for obsessive-compulsive disorder.
Symmetrical gridlines on the back of the cap extend from a common point. They guide small changes in treatment coil position between test pulses. The clinician delivers these pulses and observes the patient’s feet for involuntary movement while determining the location.
Listed Item
The OCD MT Cap is used to aid in the OCD motor threshold (MT) determination process.
When It Is Worn
The cap is an optional accessory worn only during motor threshold determination. It provides a positioning reference while the NeuroStar system supplies the magnetic pulses.
Who Else Makes It
Concentrated in Guangdong (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| 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
| 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) | K231350 |
| Record published | 2023-08-16 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | manufacturing date |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 85-00397-000 | In distribution |
Same 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 |
| SenStar Connect Treatment Link | Neuronetics Inc. | 1 |
| NeuroSITE | Neuronetics Inc. | 1 |
510(K) Clearances
| 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.