MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption
Device Facts
| Record ID | K230014 |
|---|---|
| Device Name | MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption |
| Applicant | Tonica Elektronik A/S |
| Product Code | QPL · Neurology |
| Decision Date | Aug 25, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5890 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The MagVenture Pain Therapy is intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older.
Device Story
MagVenture Pain Therapy is a magnetic stimulator system for non-invasive peripheral nerve stimulation to relieve chronic intractable, post-traumatic, and post-surgical pain. Used in hospitals and pain management clinics by clinicians. System comprises a magnetic stimulator, stimulation coils (circular or butterfly geometry), optional liquid cooling unit, and trolley. Operates by delivering brief, focused magnetic pulses to target nerves. Coils include integrated thermo-sensors to monitor surface temperature (max 43°C) and automatically disable if limits are exceeded. Healthcare providers use the device to deliver a specific treatment protocol (13-minute sessions, 0.5 Hz, 400 pulses). Output affects clinical decision-making by providing a non-pharmacological pain management option. Benefits include targeted nerve stimulation for pain relief.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on bench testing, design similarity to the previously cleared MagPro family (K091940), and performance comparisons to the predicate device (K210021).
Technological Characteristics
Magnetic stimulator; copper winding coils in PVC/ABS/PA/POM housing. Energy source: AC power via isolation transformer. Dimensions: butterfly (150mm, 160x80mm) and circular (110-126mm) coils. Connectivity: LED user interface. Safety: IEC60601-1 v3.1 compliant (electrical, mechanical, thermal, chemical). Biocompatibility: ISO 10993 compliant. Sterilization: Non-sterile. Software: Microprocessor-controlled.
Indications for Use
Indicated for patients 18 years or older suffering from chronic intractable, post-traumatic, and post-surgical pain.
Regulatory Classification
Identification
A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.
Predicate Devices
- Axon Therapy/ NeuraLace Medical, Inc. (K210021)
Reference Devices
- MagPro Family (K091940)
- MMC-140-II (K061645)
- MCF-140 (K061645)
- RT-120-II (K061645)
- MMC-90 (K061645)
- MCF-125 (K071821)
- Cool-B65 (K071821)
- Cool-125 (K071821)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 25, 2023
Tonica Elektronik A/S Dr. Kirstine Schou Medical Writer MagVenture A/S Lucernemarken 15 Farum, DK-3520 Denmark
Re: K230014
Trade/Device Name: MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption, Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: OPL Dated: August 8, 2023 Received: August 8, 2023
Dear Dr. Schou:
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.
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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 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 (QS) 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 medical devices and radiation-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.
# AmberT. Ballard -S
Amber Ballard, PhD 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
510(k) Number (if known) K230014
Device Name
MagVenture Pain Therapy: MagPro R30 with MagOption, MagPro X100, MagPro X100, MagPro X100 with MagOption
Indications for Use (Describe)
To stimulate peripheral nerves for relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older
| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Traditional 510(k) Premarket Submission MagVenture Pain Therapy TONICA ELEKTRONIK A/S
Image /page/3/Picture/1 description: The image contains the text "Tonica Elektronik A/S" in blue font. To the right of the text are two puzzle pieces, one blue and one red, that are connected. The puzzle pieces are arranged vertically, with the blue piece on top and the red piece on the bottom.
## 510(k) Summary
## 510(k) Number K230014
## DATE PREPARED
08/25/2023
## MANUFACTURER AND 510(k) OWNER
Tonica Elektronik A/S Lucernemarken 15 DK-3520 Farum, Denmark Telephone: +45 4499 1544 Official Contact: Jan Kjøller
#### REPRESENTATIVE
Kirstine Klitgaard Schou, Ph.D. Email: kks(@magventure.com Telephone: +45 6114 6675
#### DEVICE INFORMATION
Proprietary Name/Trade Name: MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption
| Common name: | Electromagnetic stimulator, pain relief |
|--------------------|------------------------------------------------------------|
| Regulation Number: | 21 CFR 882.5890 |
| Regulation Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Class: | Class II |
| Product Code: | QPL |
| Review Panel: | Physical Medicine |
## PREDICATE DEVICE IDENTIFICATION
The MagVenture Pain Therapy (K230014) is substantially equivalent to the following predicate:
| 510(k) Number | Predicate Device Name / Manufacturer | Predicate |
|---------------|---------------------------------------|-----------|
| K210021 | Axon Therapy/ NeuraLace Medical, Inc. | √ |
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Image /page/4/Picture/1 description: The image contains the text "Tonica Elektronik A/S" in blue font. To the right of the text are two puzzle pieces, one blue and one red. The puzzle pieces are interlocked, with the blue piece on top and the red piece on the bottom. The image appears to be a logo or branding element for the company Tonica Elektronik A/S.
## DEVICE DESCRIPTION
The MagVenture Pain Therapy is a magnetic stimulator system that provides brief and focused magnetic pulses in order to non-invasively stimulate peripheral nerves and provide relief of chronic intractable, post-traumatic and post-surgical pain. The subject device is intended to be used in hospitals and clinics such as pain management clinics. The device consists of Magnetic Stimulator, Stimulation Coils, Liquid Cool Unit (optional), and a Trolley. All coils of the MagVenture Pain Therapy have a built-in thermo sensor to measure the temperature of the coil surfaces to prevent high temperature on the skin of the patient or operator. The temperature allowed by the system is maximum 43°C or between 44°C for less than 10 minutes. The system will automatically disable if this maximum temperature is reached.
## INDICATIONS FOR USE
The MagVenture Pain Therapy is intended to stimulate peripheral nerves for relief of chronic intractable, post-traumatic and post-surgical pain for patients 18 years or older.
## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Tonica Elektronik A/S believes that the MagVenture Pain Therapy is substantially equivalent to the predicate device based on the information summarized here:
The subject device has a similar design and dimensions and uses similar or identical materials as the predicate device cleared in K210021. The subject device has identical technological characteristics to the MagPro Family cleared in K091940. These technological characteristics have undergone testing ensuring that the device is as safe and effective as the predicate. While both the subject and predicate device are magnetic stimulators, with similar technological characteristics, and stimulation patterns, the subject device includes circular magnetic coils in addition to the butterfly geometry of the predicate devices differ in the ranges of pulse frequencies, maximum repetition rates, and maximum output power. As discussed below, these technological differences do not raise different questions of safety and effectiveness.
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Image /page/5/Picture/1 description: The image contains the logo for Tonica Elektronik A/S. The text "Tonica Elektronik A/S" is written in blue. To the right of the text are two puzzle pieces, one red and one blue, that are connected together.
| Items | Subject device | | | Predicate device | Statement of<br>equivalence |
|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|
| Trade Name | MagVenture Pain Therapy | | | Axon Therapy | Not applicable |
| Model Name | MagPro R30<br>(K091940) | MagPro X100<br>(K091940) | MagPro X100<br>with MagOption<br>(K091940) | MagPro X100<br>with MagOption<br>(K091940) | Not applicable |
| 510(k) | K230014 | | | K210021 | Not applicable |
| Manufacturer | Tonica Elektronik A/S | | | NeuraLace Medical, Inc. | Not applicable |
| Product codes/<br>Regulation<br>Numbers | QPL (21 CFR 882.5890) | | | QPL (21 CFR 882.5890)<br>IPF (21 CFR 890.5850) | Same |
| Indications for use | The MagVenture Pain Therapy is intended to stimulate peripheral nerves for<br>relief of chronic intractable, post traumatic and post-surgical pain for<br>patients 18 years or older. | | | The Axon Therapy is<br>intended to stimulate<br>peripheral nerves for relief<br>of chronic intractable, post<br>traumatic and post-surgical<br>pain for patients 18 and<br>older | Same |
| Anatomical sites | Any area, such as hand, arm,waist, buttock, thigh, calf, back and lower back<br>etc. | | | Any area, such as hand, arm,<br>chest, waist, buttock, thigh,<br>calf, back and lower back<br>etc. | Same |
| Treatment Facilities | Hospitals & Clinics | | | Hospitals & Clinics | Same |
| Treatment time | 13 min per session (800 seconds) | | | 13 min per session (800<br>seconds) | Same |
| Pulse frequency | 0.1-30 Hz (pps) | 0.1-100 Hz (pps) | | 0-2 Hz (pps) | Substantially equivalent<br>Refer to SE note 1 |
| Pulse amplitude | 0-100% | | | 0-100% | Same |
| | | | | | |
| On-cycle duty<br>period | 2-800 seconds<br>(0.5 Hz and up to 400 pulses) | | 2-800 seconds<br>(0.5 Hz and up to 400 pulses) | Same | |
| Off-cycle reset<br>period | N/A | | N/A | Same | |
| Maximum<br>repetition rate | 30 pulses per second | 100 pulses per second | 2 pulses per second (pps) | Substantially equivalent<br>Refer to SE note 1 | |
| Pulse Width | Biphasic (280-320 µsec) | | Biphasic (290 µsec) | Substantially equivalent | |
| Pulse mode | Standard | | Standard | Same | |
| Maximum output<br>power | 100% at 15 pps | | 100% at 2 pps | Substantially equivalent<br>Refer to SE note 2 | |
| Waveform | Biphasic | Biphasic,<br>Monophasic | Biphasic | Substantially equivalent<br>All devices are capable<br>of biphasic mode | |
| Maximum coil<br>temperature | 43°C | | 41°C | Same.<br>The system will<br>automatically disable if<br>this maximum<br>temperature is reached | |
| Peak Magnetic<br>Field at coil surface<br>(T) | 1.15-2.6 T* | | Not publicly available | Substantially equivalent<br>Refer to SE note 3 | |
| Peak Magnetic<br>Field<br>Gradient dB/dt in<br>coil center at 20mm<br>distance from the<br>coil surface | 9-24 kT/s* | | Not publicly available | Substantially equivalent<br>Refer to SE note 3 | |
| Software/Firmware/<br>Microprocessor<br>control | Yes | | Yes | Same | |
| Power Source | Power Supply via Isolation Transformer<br>Power Supply: 120V~, 50/60 Hz.<br>Power consumption: Maximum 2700VA | | Power Supply: 110V to<br>220V ac, 50/60 Hz.<br>Power consumption: 800VA<br>Maximum, 115W idle | Same | |
| User Interface | LED display | | LED display | Same | |
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#### Traditional 510(k) Premarket Submission MagVenture Pain Therapy TONICA ELEKTRONIK A/S
Image /page/6/Picture/1 description: The image shows the logo for Tonica Elektronik A/S. The text "Tonica Elektronik A/S" is written in blue. To the right of the text are two puzzle pieces, one blue and one red, that are partially connected.
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#### Traditional 510(k) Premarket Submission MaqVenture Pain Therapy TONICA ELEKTRONIK A/S
Image /page/7/Picture/1 description: The image shows the logo for Tonica Elektronik A/S. The text "Tonica Elektronik A/S" is written in blue. To the right of the text are two puzzle pieces, one red and one blue, that are connected.
| Housing Material<br>Construction | Stimulator: Aluminum, Aluzinc<br>Coils: PVC, ABS, PA, POM | Stimulator: Al sheet EN AW<br>5754<br>Coil: ABS | Substantially equivalent |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|------------------------------------------------|
| Applied Parts | Magnetic coils:<br>MMC-140-II (K061645)<br>MCF-140 (K061645)<br>RT-120-II (K061645)<br>MMC-90 (K061645)<br>MCF-125 (K071821)<br>Cool-B65 (K071821)<br>Cool-125 (K071821) | Magnetic coil 60BF-NL | Substantially equivalent<br>Refer to SE note 3 |
| Applied Parts area | Butterfly coils: 150 mm<br>Circular coils:110-126 mm<br>Special coils: 160×80 mm | 160 mm | Substantially equivalent<br>Refer to SE note 3 |
| Sterilization | Non-sterile when used | Non-sterile when used | Same |
| | <b>PERFORMANCE DATA</b> | | |
| Electrical Safety | Complies with IEC60601-1 v3.1 | Complies | Same |
| Mechanical Safety | Complies with IEC60601-1 v3.1 | Complies | Same |
| Chemical Safety | Complies with IEC60601-1 v3.1 | Complies | Same |
| Thermal Safety | Complies with IEC60601-1 v3.1 | Complies | Same |
| Radiation Safety | No radiation generated | Complies | Same |
| Biocompatibility | Complies with ISO 10993 | Complies | Same |
| Standards | Company complies with EN ISO 13485 | Complies | Same |
*No technological differences from K.(91940, but the definition of Peak Magnetic Field at coil surface changed. Likewise Field Gradient at coil surface changed to lower values at a distance of 20mm from coil surface.
#### Substantial Equivalence Note 1
Comparison of subject and predicate pulse frequencies and maximum repetition rates.
The pulse frequencies of 0.1-30 Hz and maximum repetition rates of 30 pps and 100 pps of the subject device are wider and higher, respectively, than the predicate device with pulse frequencies of 0-2 Hz and a maximum repetition rate of 2 pps. These differences do not raise different questions of safety and effectiveness since:
- The subject device can stimulate at 0.5 Hz the same as the predicate device. O
- In the instructions for use, it is specified that the treatment parameter is 0.5 Hz. O
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#### Traditional 510(k) Premarket Submission MaqVenture Pain Therapy TONICA ELEKTRONIK A/S
Image /page/8/Picture/1 description: The image contains the text "Tonica Elektronik A/S" in blue font. To the right of the text are two puzzle pieces, one red and one blue. The blue puzzle piece is located above and to the right of the red puzzle piece. The image appears to be a logo for Tonica Elektronik A/S.
- o The maximum repetition rates of 30 and 100 Hz are both within the range of physiological action potentials (from 0.05 to 500 Hz) of the human nervous system and thus pose no new risk to the patients.
- The subject device is substantially equivalent to the following treatment protocol as outlined in the O instructions for use. Treatment parameters (e.g., repetition rate, pulses per trains, number of pulses, inter train interval, treatment time) that are not included in the treatment protocol have not been evaluated for effectiveness in the relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older.
#### TREATMENT PROTOCOL
Three to four treatments over two months and maintenance therapy every 6 to 8 weeks is recommended.
| Treatment level: | Individually estimated (% of maximum output power) |
|-----------------------|----------------------------------------------------|
| Repetition rate: | 0.5 pps |
| Pulses per train: | 10 |
| Number of trains: | 40 |
| Number of pulses: | 400 |
| Inter train interval: | 2 s |
| Treatment time: | 13 min |
In conclusion, higher ranges of pulse frequencies and higher maximum repetition rates do not raise any new or different questions of safety and effectiveness.
#### Substantial Equivalence Note 2
Comparison of subject and predicate maximum output power.
The maximum output power of the subject device is 100% in the range of 0.1 to 15 pps while the predicate device is 100% in the range of 0.5 to 2 pps. Consequently, at 2 pps the subject device are both able to obtain a maximum output of 100% signifying they are equally effective.
In conclusion, since both devices perform 100% at 2 pps there are no new issues of safety and effectivence in maximum output power does not raise new or different questions of safety and effectiveness.
## Substantial Equivalence Note 3
Comparison of Subject and Predicate Magnetic Coils
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Traditional 510(k) Premarket Submission MaqVenture Pain Therapy TONICA ELEKTRONIK A/S
Image /page/9/Picture/1 description: The image contains the text "Tonica Elektronik A/S" in blue font. To the right of the text are two puzzle pieces, one red and one blue. The puzzle pieces are interlocked, with the red piece slightly below and to the left of the blue piece.
The subject device has both circular and butterfly coils while the predicate only has a butterfly coil. However, all the coils are basically constructed the same way: A cobber winding element encapsulated in a plastic housing.
The size of the magnetic field depends on the diameter and number of windings only varies slightly and the diameters of the subject device coils are close to the predicate coil.
Except for minor differences in geometry, the butterfly coils of the predicate and subject devices are similar. In comparison to the butterfly geometry, the circular coil element. This gives a better usability with no roation limitation. All coils achieve the same intended use. The differences in the electric field and spatial characteristics (maximum magnetic fields at the coil surface (T) and the magnetic gradients (dB/dt)) of the circular and butterfly geometries are negligible and have no documented impact on effectiveness or safety of the intended use.
It is concluded that the differences in coil geometry do not raise new or different questions of safety and effectiveness.
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Image /page/10/Picture/1 description: The image contains the text "Tonica Elektronik A/S" in blue font. To the right of the text are two puzzle pieces, one blue and one red. The puzzle pieces are interlocked, with the blue piece on top and the red piece on the bottom.
## SUMMARY OF NON-CLINICAL TESTING
The subject device is identical to the MagPro Family device (K094019) in all features (e.g., design, dimensions, materials, biocompatibility), except for the indications for use. Therefore, no new bench testing is needed.
## DISCUSSION
The subject device has the same intended use, indications for use, and similar technological characteristics, and principles of operation as the predicate device. Also, the target population, the dosage, the treatment procedure, and all specific protocol parameters (intensity, repetition rate, number of pulses) are identical for the subject and the predicate device.
The subject device has a broader range of pulse frequencies and higher maximum repetition rates compared to the predicate device. Still, both devices are able to run the stimulation protocol of 400 pulses at 0.5 Hz. Furthermore, the maximum repetition rates of the predicate device are all within the range of physiological action potentials of the human nervous system and thus pose no new risk to the patients. The maximum output power of the subject device is higher than the predicate devices. Nevertheless, both devices perform 100% at 2 pps signifying they are equally effective. The subject device is substantially equivalent to the predicate device for the treatment protocol as described above. Treatment parameters (e.g., repetition rate, pulses per train, number of trains, number of pulses, inter train interval, treatment time) that are not included in the treatment protocol above have not been evaluated for effectiveness in the relief of chronic intractable, post traumatic and post-surgical pain for patients 18 years or older.
Finally, the subject device has both circular and butterfly coils while the predicate only has a butterfly coil. However, all the coils are basically constructed the same way: a cobber winding element encapsulated in a plastic housing. Except for minor differences in geometry, the butterfly coils of the predicate and subject devices are similar. In comparison to the butterfly geometry, the circular coils have just one coil element. This gives a better usability with no rotation limitation. All coils achieve the same intended use. The differences of the circular and butterfly geometries are negligible and do not raise new or different questions of safety and effectiveness.
## CONCLUSION
Except for the indication for use, the subject device is identical to the previously cleared MagPro family device. Thus, software validation, electrical safety testing, and performance testing can be leveraged for this device. The similar indications for use, stimulation patterns, technological characteristics, and performance characteristics for the proposed MagVenture Pain Therapy are assessed to be substantially equivalent to the predicate device.
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