KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)
Device Facts
| Record ID | K260396 |
|---|---|
| Device Name | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) |
| Applicant | Fidelity BioPharma Co. |
| Product Code | OBP · Neurology |
| Decision Date | Sep 6, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5805 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The KCS rTMS Therapy System (Transcranial Magnetic Stimulator) is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
Device Story
KCS rTMS Therapy System delivers repetitive transcranial magnetic stimulation to cerebral cortex; host unit controls stimulation parameters (frequency, intensity, duration, site) via software; stimulation coil (MD-60) generates time-varying magnetic field; induces currents in brain to change nerve cell membrane potential and generate action potentials; used in clinical settings by trained operators; output parameters (120% motor threshold, 10Hz, 3000 pulses/session) target left dorsolateral prefrontal cortex; treatment aims to influence metabolic and neural electrical activity to treat depression; system includes host, stimulation coil, and optional modules (motor evoked potential, coil stand).
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), software verification/validation, and performance testing per FDA Class II Special Controls Guidance for rTMS systems.
Technological Characteristics
Repetitive transcranial magnetic stimulation system; air-core figure-of-eight coil (MD-60) with liquid cooling; biphasic sinusoid waveform; frequency range 0.1-100 Hz; max magnetic field 0.576 T at 100% intensity; complies with IEC 60601-1, IEC 60601-1-2, ISO 13485, and ISO 14971. Software-controlled parameter delivery.
Indications for Use
Indicated for treatment of Major Depressive Disorder in adults (22+ years) who failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
Regulatory Classification
Identification
A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy.
Special Controls
*Classification.* Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document.
Predicate Devices
- Ultimate rTMS; Yingchi rTMS (K230735)
Reference Devices
- Neurosoft TMS (also CloudTMS) (K173441)
Submission Summary (Full Text)
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FDA
U.S. FOOD & DRUG
ADMINISTRATION
September 6, 2026
Fidelity BioPharma Co.
% Cassie Lee
Manager
Guangzhou Medical Consultant, Ltd.
#1919-1920, Bldg. D3
Minjie Plz., Shuixi Rd., Huang
Guangzhou, 510000 CHN
Re: K260396
Trade/Device Name: KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)
Regulation Number: 21 CFR 882.5805
Regulation Name: Repetitive Transcranial Magnetic Stimulation System
Regulatory Class: Class II
Product Code: OBP
Dated: August 7, 2026
Received: August 7, 2026
Dear Cassie Lee:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K260396 - Cassie Lee
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
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K260396 - Cassie Lee
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Sincerely,
# PAMELA D. SCOTT -S
Pamela D. 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
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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260396 | ? |
| Please provide the device trade name(s). | | ? |
| KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) | | |
| Please provide your Indications for Use below. | | ? |
| The KCS rTMS Therapy System (Transcranial Magnetic Stimulator) is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. | | |
| Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? |
| Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? |
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# 510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
# 1. Submitter's Information
Sponsor Name: Fidelity BioPharma Co.
Address: 157 Church Street, Suite 1915, New Haven, CT 06510 USA
Contact Person (including title): Song Lin (President and CEO)
Tel: (203)889-8028, +86 15068875329
E-mail: song.lin@fbpus.com
# Application Correspondent:
Application Correspondent:
Contact Person: Ms. Cassie Lee
Share Info (Guangzhou) Medical Consultant Ltd.
Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China
Tel: +86 20 8266 2446
Email: 382198657@qq.com
# 2. Summary Prepared Date
4 September 2026
# 3. Subject Device Information
Trade Name: KCS rTMS Therapy System (Transcranial Magnetic Stimulator)
Model: MetaStim 100, MetaStim 100A
Regulation: 21 CFR 882.5805
Regulation Name: Repetitive transcranial magnetic stimulation system
Regulatory Class: Class II
Product Code: OBP
# 4. Predicate Device Information
# Primary predicate:
Sponsor: Brain Ultimate, Inc.
Trade Name: Ultimate rTMS; Yingchi rTMS
Regulation: 21 CFR 882.5805
510(k) Number: K230735
Regulation Name: Repetitive transcranial magnetic stimulation system
Regulatory Class: Class II
Product Code: OBP
# Reference device 1
Sponsor: TeleEMG, LLC
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Trade Name: Neurosoft TMS (also CloudTMS)
Regulation: 21 CFR 882.5805
510(k) Number: K173441
Regulation Name: Repetitive transcranial magnetic stimulation system
Regulatory Class: Class II
Product Code: OBP
### 5. Device Description
The KCS rTMS Therapy System (Transcranial Magnetic Stimulator) consists of a host and a stimulation coil; optional modules include motor evoked potential, coil stand, and MetaStim series operating software. The host includes the master control unit, power supply, lower machine application software, and cooling unit. Each model has a stimulation coil (MD-60).
The equipment sets parameters for stimulation mode, frequency, intensity, interval, duration, and stimulation site through MetaStim series operating software or lower machine application software, where current passing through the stimulation coil generates a time-varying magnetic field that acts on the cerebral cortex to produce induced currents, thereby changing the membrane potential of nerve cells, generating action potentials to influence metabolic and neural electrical activities in the brain.
### 6. Intended Use / Indications for Use
The KCS rTMS Therapy System (Transcranial Magnetic Stimulator) is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
### 7. Comparison to Predicate Device
Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions and the applicable standards. The differences between subject device and predicate device do not raise and new questions of safety or effectiveness.
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# **Comparison in Detail(s):**
| Elements of Comparison | Subject Device | Primary predicate | Reference device 1 | Verdict |
| --- | --- | --- | --- | --- |
| Company | Fidelity BioPharma Co. | Brain Ultimate, Inc. | TeleEMG, LLC | -- |
| Trade Name | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) | Ultimate rTMS; Yingchi rTMS | Neurosoft TMS (also CloudTMS) | -- |
| 510(k) Number | Applying | K230735 | K173441 | -- |
| Product Code | OBP | OBP | OBP | Same |
| Device classification | Class II | Class II | Class II | Same |
| Regulation number | 21 CFR 882.5805 | 21 CFR 882.5805 | 21 CFR 882.5805 | Same |
| Intended use (indication for use) | The KCS rTMS Therapy System (Transcranial Magnetic Stimulator) is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. | The Ultimate rTMS is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. | The Neurosoft TMS is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. | Same |
| Recommended Standard Treatment | | | | |
| Magnetic Field Intensity | 120% of the MT | 120% of the MT | 120% of the MT | Same |
| 120% of the MT | 10Hz | 10 Hz | 10 Hz | Same |
| Train duration | 4 sec | 4 sec | 4 sec | Same |
| Inter-train interval | 11-26 sec | 11-26 sec | 11-26 sec | Same |
| Number of trains | 75 | 75 | 75 | Same |
| Magnetic Pulses per Session | 3000 | 3000 | 3000 | Same |
| Treatment Session Duration | 18.8-37.0 min | 18.8-37.0 min | 18.8-37.0 min | Same |
| Sessions/week | 5 | 5 | 5 | Same |
| Treatment Schedule | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | 5 daily sessions for 6 weeks | Same |
| Area of brain to be stimulated | Left Dorsolateral Prefrontal Cortex | Left Dorsolateral Prefrontal Cortex | Frontal Cortex | Same |
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| Elements of Comparison | Subject Device | Primary predicate | Reference device 1 | Verdict |
| --- | --- | --- | --- | --- |
| Coils | | | | |
| Coils (including optional accessories) | MD-60 | BY90A BF90A BY90B | FEC-02-100-C; AFEC-02-100-C FEC-02-100 (optional), AFEC-02-100 (optional) | -- |
| Configuration | MD-60: Figure-of-eight coil | BY90A : Figure-of-eight coil BF90A : Figure-of-eight coil BY90B : Figure-of-eight coil With angle 120° | Figure-of-eight coil | Same |
| Core material | Air core | Air core | Air core | Same |
| Air core | Liquid cooling | BY90A: Liquid cooling BF90A: Forced Air cooling BY90B: Liquid cooling | FEC-02-100-C & AFEC-02-100-C : liquid cooling FEC-02-100 & AFEC-02-100 (optional accessories): none | Same |
| Coil parameters | MD-60: Inner diameter: 50mm Outer diameter: 81mm N = 2 wings x 4 layers x 3 turns | BY90A:Inner diameter - 34 mm Outer diameter - 85 mm N = 2 wings x 2 | FEC-02-100-C: ID-47x50mm; OD-97x100mm; Area=184725mm²; Average | Similar Note 1 |
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| Elements of Comparison | Subject Device | Primary predicate | Reference device 1 | Verdict |
| --- | --- | --- | --- | --- |
| | | layers x 5 turns BF90A:Inner diameter - 34 mm Outer diameter - 85 mm N = 2 wings x 2 layers x 5 turns BY90B:Inner diameter - 30 mm Outer diameter -90 mm N = 2 wings x 2 layers x 6 turns | inductance 10 μH; Flat spiral winding N=16 turns (2 layers x2 wrings) AFEC-02-100-C: ID-36x51mm; OD-84x106mm; Area=184725mm²; Average inductance 10 μH; Flat spiral winding N=16 turns (2 layers x2 wrings) FEC-02-100: ID-47x50mm; OD-97x100mm; Area=91560mm²; Average inductance 10 μH; Flat spiral winding N=16 turns (2 layers x2 wrings) AFEC-02-100: ID-36x51mm; OD-84x106mm; Area=87200mm²; Average inductance 10 μH; Flat spiral winding N=16 turns (2 layers x2 wrings) | |
| Machine output parameters | | | | |
| Amplitude in Standard Motor Threshold (SMT) units | 0-1.83 54.6% Intensity Setting 1 SMT | 0 - 1.9 52.6% Intensity Setting → 1 SMT | FEC-01-100-C 0-1.89 AFEC-02-100-C 0-2.38 FEC-02-100 0-1.92 AFEC-02-100 0-2.33 | Similar Note 2 |
| Waveform | Biphasic sinusoid | Biphasic sinusoid | Biphasic sinusoid | Same |
| Active pulse width (μs) | 330 | 320 | 280 | Similar Note 3 |
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| Elements of Comparison | Subject Device | Primary predicate | Reference device 1 | Verdict |
| --- | --- | --- | --- | --- |
| Pulse amplitude (V) | 1.4±10% | BY90A: 1.35 BF90A: 1.26 BY90B: 1.22 | Not public available | Similar Note 3 |
| Max magnetic field strength 2 cm from coil (T) | At 25% Intensity: 0.182 At 50% Intensity: 0.292 At 75% Intensity: 0.438 At 100% Intensity: 0.576 | At 25% Intensity: BY90A: 0.172 BF90A: 0.182 BY90B: 0.117 At 50% Intensity: BY90A: 0.291 BF90A: 0.287 BY90B: 0.244 At 75% Intensity: BY90A: 0.403 BF90A: 0.395 BY90B: 0.369 At 100% Intensity: BY90A: 0.498 BF90A: 0.494 BY90B: 0.481 | Not public available | Similar Note 4 |
| Max initial dB/dt (kT/s) near the coil surface (z = 0 cm) | 11.54 | BY90A: 13.44 BF90A: 13.76 BY90B: 12.10 | Max initial dB/dt (kT/s) near the coil surface: FEC-01-100-C 25 AFEC-02-100-C 38 FEC-02-100 25 AFEC-02-100 32 | Similar Note 5 |
| Max initial dB/dt (kT/s) 2 cm from coil surface (z = 2 cm) | 4.58 | BY90A: 3.59 BF90A: 4.27 BY90B: 6.78 | | |
| The system will automatically be disabled when the coil temperature exceeds | 43 °C | 40 °C (104 °F) | 41 °C (106 °F) | Similar Note 6 |
| Frequency range (Hz) | 0.1 - 100 | 0.1 - 10 | 0.1-30 (stand-alone) 0.1-100 (with PC) | Same |
| Pulse train duration range (s) | Rep Rate: 0.1 ...100Hz Pulses in Train: 1,2,3,4 ... 1000 Train duration = Pulses in Train / Rep Rate | Rep Rate: 0.1 ...100Hz Pulses in Train: 1,2,3,4 ... 2000 Train duration = Pulses in Train / Rep Rate | 0.5-100 | Similar Note 8 |
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| Elements of Comparison | Subject Device | Primary predicate | Reference device 1 | Verdict |
| --- | --- | --- | --- | --- |
| Inter-train interval range (s) | 1-100s | 0~60s | 0-300 | Similar Note 8 |
| Standards | | | | |
| Electrical safety | Complies with IEC 60601-1-, IEC 60601-1-2 | Complies with IEC 60601-1-, IEC 60601-1-2 | Complies with IEC 60601-1-, IEC 60601-1-2 | Same |
| ISO Standards met | Company complies with ISO 13485: 2016, ISO 14971 | Company complies with ISO 13485: 2016, ISO 14971 | Company complies with DIN EN ISO 13485: 2012 ISO 10993-1: 2009 ISO 14971 | Same |
**Comparison in Detail(s):**
**Note 1:**
Although the coil parameter of subject device is different from predicate device, there out parameter are similar. So, this difference will not raise issue of safety and effectiveness.
**Note 2:**
The Amplitude in Standard Motor Threshold (SMT) units of subject device is similar to the K230735 and the FEC-01-100-C of K173441. These values indicate the subject device will need a larger intensity setting to achieve the same level of induced current as the predicate device. Therefore, this difference is minor and will not raise issue of safety and efficacy.
**Note 3:**
The pulse width of subject device is close to K230735.
Since a patient is always treated at 120% MT for MDD on any TMS device, and MT is a function of both the intensity/amplitude and pulse width (higher pulse width will require lower intensity/amplitude to reach MT), differences in pulse widths are easily
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compensated by the changes in intensity settings needed to achieve 120% MT stimulation.
And slightly higher pulse width of subject device compared to K230735 would require slightly lower intensity/amplitude setting on subject device compared to K230735 to achieve the same stimulation level.
Therefore, this difference is minor and will not raise issue of safety and efficacy.
#### Note 4:
The max magnetic field values for the subject and K230735 at 2cm are in a narrow range and exhibit equivalent slope and intercept values when measured at 25%, 50%, 75% and 100% intensity settings, as shown below:
These measurements were made using the same intensity setting, for a treatment given to the same patient, each device will be set to 120% of the patient's MT, which does not translate to the exact same % intensity on each device.
#### Note 5:
The dB/dt values for the subject device and K230735 at z=0 and z=20mm are very close. For a treatment given to the same patient, each device will be set to 120% of the patient's MT, which does not translate to the exact same % intensity on each device. Therefore, the slightly difference will not impact safety or effectiveness.
#### Note 6:
The coil is not intended to be in direct contact with patient, and the maximum temperature \( 43\ °C \) meet the clause 11.1.1 of IEC 60601-1. Therefore, this difference will not raise issue of safety.
#### Note 7:
The differences in pulse rain duration range, inter-train interval range, maximum number
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of pulses per session are the differences in the overall capabilities of the devices, these capabilities encompass the recommended treatment parameters for MDD list above. These differences do not impact the ability to deliver the treatment parameters recommended for MDD. Therefore, the difference will not raise issue of safety or effectiveness.
## 8. Test Summary
### 8.1 Summary of Non-Clinical Performance Testing
#### 1) Electrical safety, and electromagnetic compatibility Test
The KCS rTMS Therapy System (Transcranial Magnetic Stimulator) has been evaluated the safety and performance by lab bench testing as following:
| Standards No. | Standard Title | Version | Recognition Number |
| --- | --- | --- | --- |
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Edition 3.2 2020-08 | 19-49 |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | Edition 4.1 2020-09 | 19-36 |
#### 2) Software verification and validation
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Device Software Functions" The software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
#### 3) Cybersecurity
Cybersecurity evaluation was conducted according to FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices". The device has been found to be safe.
#### 4) Performance testing
Performance testing was conducted according to the FDA guidance "Guidance for Industry and Food and Drug Administration Staff-Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems".
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## 8.2 Clinical Performance
Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.
## 9. Conclusion
The subject device is as safe, as effective, and performs as well as or better than the legally marketed K230735, K173441.
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