(30 days)
Not Found
No
The description focuses on the electromechanical and magnetic stimulation aspects of the device. There are no mentions of AI, ML, or related concepts in the provided text.
Yes
The device is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD), which directly indicates a therapeutic purpose.
No
The device is described as a transcranial magnetic stimulation (TMS) system intended for the treatment of Obsessive-Compulsive Disorder (OCD), not for diagnosis.
No
The device description explicitly lists multiple hardware components, including a Mobile Console, Treatment Chair, Ferromagnetic Treatment Coil, and Head Support System, in addition to the System Software. This indicates it is a system with both hardware and software, not a software-only medical device.
Based on the provided information, the NeuroStar Advanced Therapy system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the treatment of Obsessive-Compulsive Disorder (OCD) by applying magnetic stimulation to the brain. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a transcranial magnetic stimulation (TMS) system that delivers magnetic pulses to the brain. This is a physical treatment modality.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
Therefore, the NeuroStar Advanced Therapy system falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
Product codes (comma separated list FDA assigned to the subject device)
QCI
Device Description
The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region.
The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components:
- Mobile Console
- System Software
- Treatment Chair
- Ferromagnetic Treatment Coil
- Head Support System
- SenStar® Connect Treatment Link & SenStar® Treatment Link
- Treatment Pack (for use with the SenStar® Connect Treatment Link)
- MT Cap
- TrakStar™ Patient Data Management System
- D-Tect™ MT Accessory
- Beam F3 Treatment Pack
- OCD MT Cap
The only proposed change to the NeuroStar Advanced Therapy System is the addition the OCD MT Cap, a single-use wearable device that is intended to be used as an optional aid during the OCD Motor Threshold (MT) determination process. It is only worn by the patient during the MT determination process as a quide to facilitate determination of the patient's unique MT location. The OCD MT Cap outer surface contains a symmetrical gridlines that are centered on the back of the head and stem from a single point. These gridlines enable the clinician to easily move the coil incrementally without the need for manually moving the Anterior/Posterior (A/P) and Superior Oblique Anqle (SOA) indicators to incrementally move the Treatment Coil between MT pulses. As the MT pulses are delivered to the patient during this process, the clinician monitors the patient for involuntary movement in the foot/feet in exactly the same manner as the current method.
There are no changes to the NeuroStar Advanced Therapy System nor to any other accessory to the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Bilateral dorsomedial prefrontal cortex
Indicated Patient Age Range
Adult patients (ages 22-70)
Intended User / Care Setting
Inpatient and outpatient settings including physician's offices and clinics, hospitals, and general medical/surgical hospitals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
The contents of this 510(k) comply with the FDA Guidance Document: "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems - Guidance for Industry and Food and Drug Administration Staff."
A biocompatibility risk assessment was performed in accordance with ISO 10993-1 and the FDA Guidance Documents "Use of International Standard ISO 10993-1 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process' and revealed no biocompatibility concerns.
Additionally, usability testing was completed in accordance with FDA Guidance Document: "Applying Human Factors and Usability Engineering to Medical Devices," using IEC 62366-1 as a quide.
To summarize, the results of verification and validation testing confirmed that the OCD MT Cap can be successfully used to aid clinicians in the MT determination process to determine the patient's unique MT location.
Clinical Testing:
There is no clinical testing required to support this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5802 Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions.
(a)
Identification. A transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions is a prescription, non-implantable device that uses brief duration, rapidly alternating, or pulsed, magnetic fields to induce neural activity in the cerebral cortex. It is not intended for applying or focusing magnetic fields towards brain areas outside cerebral cortex (e.g., cerebellum). A repetitive transcranial magnetic stimulation system that is intended to treat major depressive disorder is classified in § 882.5805. A transcranial magnetic stimulation system for headache is classified in § 882.5808.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Performance testing must demonstrate electromagnetic compatibility, electrical safety, and thermal safety.
(2) Software verification, validation, and hazard analysis must be performed.
(3) The patient-contacting components of the device must be demonstrated to be biocompatible.
(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Magnetic pulse output testing;
(ii) Magnetic and electrical field testing;
(iii) Testing of the safety features built into the device; and
(iv) Testing of the sound levels patients are exposed to during device use.
(5) The physician and patient labeling must include the following:
(i) The risks and benefits associated with use of the device;
(ii) Detailed instructions to prevent seizures, to monitor the patient for seizure activity during treatment, and to provide seizure management care if one were to occur during treatment; and
(iii) A description of the ear protection to be worn by the patient during use of the device, including the type of protection and its noise reduction rating.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
June 8, 2023
Neuronetics Amanda Pentecost, PhD Sr. Regulatory Affairs Specialist 3222 Phoenixville Pike Malvern, Pennsylvania 19355
Re: K231350
Trade/Device Name: OCD MT Cap (85-00397-000) Regulation Number: 21 CFR 882.5802 Regulation Name: Transcranial magnetic stimulation system for neurological and psychiatric disorders and conditions Regulatory Class: Class II Product Code: QCI Dated: May 1, 2023 Received: May 9, 2023
Dear Dr. Pentecost:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Kang -S
for Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K231350
Device Name OCD MT Cap (85-00397-000)
Indications for Use (Describe)
The NeuroStar Advanced Therapy system is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image is a logo for NeuroStar, a company that provides advanced therapy for mental health. The logo features the word "NeuroStar" in a stylized font, with the words "Advanced Therapy for Mental Health" underneath. Above the word "NeuroStar" is a graphic of a star made up of people holding hands. The logo is purple and white.
| 510(k) Summary | |
|---|---|
| Date Prepared: | June 7, 2023 |
| Applicant: | Neuronetics, Inc. |
| 3222 Phoenixville Pike | |
| Malvern, PA 19355 | |
| Contact Person: | Amanda Pentecost, PhD |
| Sr. Regulatory Affairs Specialist | |
| Phone: 610-640-4202, ext. 1132 | |
| Email: amanda.pentecost@neurostar.com | |
| Secondary Contact: | Robin Fatzinger |
| Sr. Director, Regulatory and Medical Affairs | |
| Phone: 610-640-4202, ext. 1064 | |
| Email: robin.fatzinger@neurostar.com | |
| Device Trade Name: | NeuroStar |
| NeuroStar TMS Therapy System | |
| NeuroStar Advanced Therapy System | |
| NeuroStar Advanced Therapy System for Mental Health | |
| Device Common Name: | Transcranial Magnetic Stimulator |
| Classifications: | 21 CFR 882.5802 |
| Product Codes: | QCI |
| Predicate Device: | NeuroStar Advanced Therapy System (K212289, K230029) |
| (Product Code: QCI) |
Image /page/3/Picture/5 description: The image shows a logo with the letters "NS" in a stylized font. The letters are purple and are positioned to the left of a star-like shape. The star shape is also purple and appears to be formed by stylized figures with outstretched arms, giving the impression of people reaching towards the center of the star. The overall design is simple and modern.
4
Device Description / Technological Characteristics:
The NeuroStar Advanced Therapy System is a transcranial magnetic stimulation device. Specifically, it is a computerized, electromechanical device that produces and delivers non-invasive magnetic fields to induce electrical currents targeting specific regions of the cerebral cortex. Transcranial magnetic stimulation (TMS) is a non-invasive technique used to apply brief magnetic pulses to the brain. The pulses are administered by passing high currents through an electromagnetic coil placed adjacent to a patient's scalp. The pulses induce an electric field in the underlying brain tissue. When the induced field is above a certain threshold and is directed in an appropriate orientation relative the brain's neuronal pathway, localized axonal depolarizations are produced, thus activating neurons in the targeted brain region.
The NeuroStar Advanced Therapy System is an integrated system consisting of a combination of the following components:
- Mobile Console •
- . System Software
- . Treatment Chair
- Ferromagnetic Treatment Coil .
- . Head Support System
- . SenStar® Connect Treatment Link & SenStar® Treatment Link
- Treatment Pack (for use with the SenStar® Connect Treatment Link)
- . MT Cap
- . TrakStar™ Patient Data Management System
- . D-Tect™ MT Accessory
- Beam F3 Treatment Pack
- OCD MT Cap
Proposed Change:
The only proposed change to the NeuroStar Advanced Therapy System is the addition the OCD MT Cap, a single-use wearable device that is intended to be used as an optional aid during the OCD Motor Threshold (MT) determination process. It is only worn by the patient during the MT determination process as a quide to facilitate determination of the patient's unique MT location. The OCD MT Cap outer surface contains a symmetrical gridlines that are centered on the back of the head and stem from a single point. These gridlines enable the clinician to easily move the coil incrementally without the need for manually moving the Anterior/Posterior (A/P) and Superior Oblique Anqle (SOA) indicators to incrementally move the Treatment Coil between MT pulses. As the MT pulses are delivered to the patient during this process, the clinician monitors the patient for involuntary movement in the foot/feet in exactly the same manner as the current method.
There are no changes to the NeuroStar Advanced Therapy System nor to any other accessory to the system.
Image /page/4/Picture/22 description: The image shows a logo with the letters 'NS' in bold, purple font. Above and around the letters are stylized figures that resemble people with outstretched arms, also in purple. These figures are arranged to create a star-like shape, adding a sense of dynamism and energy to the logo. The overall design is simple yet eye-catching, suggesting a focus on people and community.
5
Image /page/5/Picture/0 description: The image is a logo for NeuroStar. The logo is purple and features the word "NeuroStar" in a bold, sans-serif font. Below the word "NeuroStar" is the phrase "Advanced Therapy for Mental Health" in a smaller, sans-serif font. To the right of the word "NeuroStar" is a stylized star with two figures at the top.
Indications for Use:
The NeuroStar Advanced Therapy System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
Performance Standards:
The OCD MT Cap has been tested and conforms to the following recognized consensus standards:
- . ISO 10993-1
Non-clinical Testing:
The contents of this 510(k) comply with the FDA Guidance Document: "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems - Guidance for Industry and Food and Drug Administration Staff."
A biocompatibility risk assessment was performed in accordance with ISO 10993-1 and the FDA Guidance Documents "Use of International Standard ISO 10993-1 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process' and revealed no biocompatibility concerns.
Additionally, usability testing was completed in accordance with FDA Guidance Document: "Applying Human Factors and Usability Engineering to Medical Devices," using IEC 62366-1 as a quide.
To summarize, the results of verification and validation testing confirmed that the OCD MT Cap can be successfully used to aid clinicians in the MT determination process to determine the patient's unique MT location.
Clinical Testing:
There is no clinical testing required to support this submission.
Conclusion:
The NeuroStar Advanced Therapy System and the predicate device have the same intended uses and technological characteristics. The use of the optional OCD MT Cap accessory does not raise any different questions regarding safety or effectiveness.
Image /page/5/Picture/18 description: The image shows a logo with the letters "NS" in a bold, sans-serif font, colored in purple. The letters are stylized and integrated with a graphic element that resembles stylized human figures or abstract shapes, also in purple. The overall design is modern and suggests a sense of community or connection.
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Image /page/6/Picture/0 description: The image shows the NeuroStar logo. The logo features the word "NeuroStar" in a bold, purple font. Below the word is the text "Advanced Therapy for Mental Health" in a smaller font. To the right of the word is a star-shaped graphic with stylized figures.
NeuroStar.com
Technological Comparison
| | NeuroStar Advanced Therapy System
(Subject Device) | NeuroStar Advanced Therapy System
(Predicate Device – K212289, K230029) | Explanation of
Differences |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The NeuroStar Advanced Therapy System is
intended to be used as an adjunct for the
treatment of adult patients suffering from
Obsessive-Compulsive Disorder (OCD) | The NeuroStar Advanced Therapy System is
intended to be used as an adjunct for the treatment
of adult patients suffering from Obsessive-
Compulsive Disorder (OCD) | No Difference |
| Intended Use | Obsessive Compulsive Disorder | Obsessive Compulsive Disorder | No Difference |
| Anatomical Sites | Bilateral dorsomedial prefrontal cortex | Bilateral dorsomedial prefrontal cortex | No Difference |
| Target Population | Adult patients (ages 22-70) with Obsessive-
Compulsive Disorder | Adult patients (ages 22-70) with Obsessive-
Compulsive Disorder | No Difference |
| Clinical Setting | Inpatient and outpatient settings including
physician's offices and clinics, hospitals, and
general medical/surgical hospitals. | Inpatient and outpatient settings including
physician's offices and clinics, hospitals, and general
medical/surgical hospitals. | No Difference |
| Materials | Standard materials commonly used in the
manufacture of electrical medical devices | Standard materials commonly used in the
manufacture of electrical medical devices | No Difference |
| Biocompatibility | Patient-contacting device components use
standard materials compliant with ISO 10993-1
that are commonly used in consumer products
and medical device applications | Patient-contacting device components use standard
materials compliant with ISO 10993-1 that are
commonly used in consumer products and medical
device applications | No Difference |
| Energy Source | Power console with magnetic coil for delivery
for magnetic energy | Power console with magnetic coil for delivery for
magnetic energy | No Difference |
| Electrical Safety & EMC | IEC 60601-1 compliant
IEC 60601-1-2 compliant | IEC 60601-1 compliant
IEC 60601-1-2 compliant | No Difference |
| Communication with
TrakStar | Wireless (Wi-fi) and
Ethernet cable | Wireless (Wi-fi) and
Ethernet cable | No Difference |
| Sterility | No parts of the device, accessories or
components are required to be sterilized | No parts of the device, accessories or components
are required to be sterilized | No Difference |
| Coil Type | Ferromagnetic
Iron core | Ferromagnetic
Iron core | No Difference |
| | Internal cooling fan | Internal cooling fan | |
| Coil Positioning System | Integrated into Head Support System
Laser-aided coil placement | Integrated into Head Support System
Laser-aided coil placement | No Difference |
| Treatment Schedule | Weeks 1-5: 1 treatment session per day for 5
days
Week 6: 1 treatment session per day for 4 days
Total of 29 treatment sessions | Weeks 1-5: 1 treatment session per day for 5 days
Week 6: 1 treatment session per day for 4 days
Total of 29 treatment sessions | No Difference |
| Device Components | Mobile Console
Ferromagnetic Coil for delivering
treatment
Head Support System for coil positioning
MT Cap for coil positioning*
D-Tect™ MT Accessory for MT location
and level determination*
Multi-use disposable for contact sensing
and magnetic field quality control
Single-use treatment pack including
disposable hygienic barriers and coil
positioning head strap for use with the
standard 5 cm method
Single-use treatment pack including
disposable hygienic barriers and head
strap for use with the Beam F3 method for
determining treatment location and coil
positioning*
OCD MT Cap for Coil positioning
TrakStar System for recording patient data | Mobile Console
Ferromagnetic Coil for delivering treatment
Head Support System for coil positioning
MT Cap for coil positioning*
D-Tect™ MT Accessory for MT location and
level determination*
Multi-use disposable for contact sensing and
magnetic field quality control
Single-use treatment pack including disposable
hygienic barriers and coil positioning head strap
for use with the standard 5 cm method
Single-use treatment pack including disposable
hygienic barriers and head strap for use with
the Beam F3 method for determining treatment
location and coil positioning*
TrakStar System for recording patient data | Different
The addition of the
OCD MT Cap is the
subject of this
510(k).
*Note: The MT Cap,
D-Tect™ MT
Accessory, and Beam
F3 Treatment Pack
are not intended to
be used as part of
the OCD treatment
protocol. |
| %MT Range | 25% to 140% MT | 25% to 140% MT | No Difference |
| Pulses per Second (PPS)
Range | For treatment: 1 to 30 PPS
For MT determination: 0.1-0.3 PPS | For treatment: 1 to 30 PPS
For MT determination: 0.1-0.3 PPS | No Difference |
| Induced Electrical field at 2
cm at 1.0 SMT | 135 V/m (Nominal) | 135 V/m (Nominal) | No Difference |
| Pulse Type | Biphasic Sinusoid | Biphasic Sinusoid | No Difference |
| Pulse Width | 185 µS (Nominal) | 185 µS (Nominal) | No Difference |
| Treatment Protocols | Level: 100% foot motor threshold level
Repetition Rate: 20 PPS
Stimulation Time: 2 s
Inter-train Interval: 20 s
Session Duration: As low as 18.3 min
Pulses per Session: 2000
Sessions Per Week: 5 for Weeks 1-5 and 4 for
Week 6 | Level: 100% foot motor threshold level
Repetition Rate: 20 PPS
Stimulation Time: 2 s
Inter-train Interval: 20 s
Session Duration: As low as 18.3 min
Pulses per Session: 2000
Sessions Per Week: 5 for Weeks 1-5 and 4 for
Week 6 | No Difference |
| Treatment Level Range | 0.22 to 2.08 SMT
Calibrated linear output | 0.22 to 2.08 SMT
Calibrated linear output | No Difference |
| Stimulation Time Pulse Train
Duration Range | 1 PPS: 1 to 600 s
1 PPS: 1 to 20 s | 1 PPS: 1 to 600 s
1 PPS: 1 to 20 s | No Difference |
| Inter-train Interval Range | 1 PPS: 0 to 600 s
1 PPS: 10 to 60 s | 1 PPS: 0 to 600 s
1 PPS: 10 to 60 s | No Difference |
| Pulse per Treatment Session | Nominal: 2000
Maximum: 5000 | Nominal: 2000
Maximum: 5000 | No Difference |
Image /page/6/Picture/6 description: The image shows a logo with the letters "NS" in bold, purple font. The letters are slightly overlapping, with the "S" positioned behind the "N". Above the letters is a stylized star shape, also in purple, with curved lines extending from the center to form the points of the star. The overall design is simple and modern, with a focus on the letters and the star symbol.
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Image /page/7/Picture/0 description: The image shows the logo for NeuroStar, a company that provides advanced therapy for mental health. The logo features the word "NeuroStar" in a stylized font, with the words "Advanced Therapy for Mental Health" underneath. To the right of the word "NeuroStar" is a graphic of a star made up of people.
NeuroStar.com
Image /page/7/Picture/5 description: The image shows a logo with the letters "NS" in a stylized font. The letters are purple and are positioned to the left of a star-like shape. The star shape is also purple and has two figures with outstretched arms at the top, suggesting a sense of community or achievement. The overall design is simple and modern, likely representing an organization or brand with the initials "NS".
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Image /page/8/Picture/0 description: The image shows the logo for NeuroStar. The logo is purple and consists of the word "NeuroStar" in a bold, sans-serif font. Below the word "NeuroStar" is the phrase "Advanced Therapy for Mental Health" in a smaller, lighter font. To the right of the word "NeuroStar" is a stylized star shape with small circles at the end of each point.
t 610 640 4202 / ƒ 610 640 4206
NeuroStar.com
Image /page/8/Picture/5 description: The image shows a logo with the letters "NS" in a bold, sans-serif font, colored in purple. Above the letters, there is a stylized star-like shape formed by three abstract figures with outstretched arms, also in purple. The figures are arranged in a semi-circle, creating the impression of a starburst or a group of people reaching upwards. The overall design is simple and modern, suggesting themes of community, achievement, or aspiration.