StimRouter Neuromodulation System

K211965 · Bioness, Inc. · GZF · Feb 23, 2022 · Neurology

Device Facts

• Record ID: K211965
• Device Name: StimRouter Neuromodulation System
• Applicant: Bioness, Inc.
• Product Code: GZF · Neurology
• Decision Date: Feb 23, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5870
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.

Device Story

StimRouter Neuromodulation System provides electrical stimulation to peripheral nerves for chronic pain management. System components: implanted lead with receiver, external pulse transmitter (E-EFC), hydrogel electrode patch, clinician programmer (tablet), and patient-use smartphone app (MAPP). Clinician implants lead percutaneously; lead captures transcutaneous electrical signals from E-EFC (mounted on skin via patch) and delivers them to target nerve. E-EFC generates stimulation pulses; controlled wirelessly via MAPP or clinician programmer. E-EFC uses BLE for communication. Patients use MAPP or integrated E-EFC buttons to adjust therapy levels. System aids pain management, potentially reducing reliance on other therapies like medications.

Clinical Evidence

No clinical data. Performance testing included electrical compatibility/safety, wireless coexistence, biocompatibility, shipping/storage, shelf life, functional verification, usability, and software verification/validation.

Technological Characteristics

Implantable lead: silicone-insulated helical coil, platinum-iridium electrodes. E-EFC: Tritan copolyester housing, STM32L151 microcontroller, nRF52832 BLE module, USB-C charging. Stimulation: monopolar, biphasic, charge-balanced, 1-200 Hz, 0-5mA (at lead), 130V max compliance. Connectivity: BLE 2.4 GHz. Software: embedded firmware and smartphone app (MAPP).

Indications for Use

Indicated for pain management in adults with severe intractable chronic pain of peripheral nerve origin, as an adjunct to other therapies (e.g., medications). Not for craniofacial pain.

Regulatory Classification

Identification

An implanted peripheral nerve stimulator for pain relief is a device that is used to stimulate electrically a peripheral nerve in a patient to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed around a peripheral nerve and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.

Predicate Devices

• StimRouter Neuromodulation System (K200482)

Reference Devices

• Dakmed 750 DPNS (K791047)

Submission Summary (Full Text)

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February 22, 2022

Bioness Inc. Sageev George, Ph.D. Regulatory Affairs Manager, Implantables 25103 Rye Canyon Loop Valencia, California 91355

Re: K211965

Trade/Device Name: StimRouter Neuromodulation System Regulation Number: 21 CFR 882.5870 Regulation Name: Implanted Peripheral Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: GZF Dated: January 21, 2022 Received: January 24, 2022

Dear Dr. Sageev George:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Amber Ballard, Ph.D. 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) K211965

Device Name StimRouter Neuromodulation System

Indications for Use (Describe)

The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.

Type of Use (Select one or both, as applicable):

| <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="text-decoration: underline;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| <div style="display:inline-block;"><b> </b></div> | <div style="display:inline-block;"></div> |

> Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange star-like symbol on the left and the word "Bioness" in gray on the right. The "i" in Bioness is dotted with an orange circle, matching the color of the star-like symbol.

Image /page/3/Picture/1 description: The image shows the logo for LiveOn. The word "Live" is in gray, and the word "On" is in orange. There is a trademark symbol in the upper right corner of the word "On".

# 510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92:

| I. | Submitter Information | |
|------|--------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Company: | Bioness Inc.<br>25103 Rye Canyon Loop<br>Valencia, CA 91355 USA<br>Phone Number: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| | Contact: | Sageev George<br>Senior Regulatory Affairs Manager, Implantables<br>Bioness Inc.<br>Phone Number: [phone]<br>Fax Number: [phone]<br>Email: [e-mail] |
| | | Sharon Klugewicz<br>Sr. Vice President, Quality & Regulatory Affairs<br>Bioventus Inc.<br>Phone Number: [phone]<br>Email: [e-mail] |
| | Date Prepared: | January 21, 2022 |
| II. | Name of Device | |
| | Device Trade Name:<br>Classification Name: | StimRouter Neuromodulation System<br>Implantable peripheral nerve stimulator for pain<br>relief |
| | Common Name: | Implantable Neurostimulator |
| | Product Code: | GZF |
| | Regulation Number: | 21 CFR §882.5870 |
| | Device Class:<br>Panel Identification: | Class II<br>Neurology |
| III. | Predicate Device | |
| | Predicate Manufacturer: | Bioness Inc. |

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Image /page/4/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange sun-like symbol on the left and the word "Bioness" in gray on the right. The "i" in Bioness has an orange dot above it. There is a registered trademark symbol to the right of the word Bioness.

Predicate Trade Name: Predicate 510(k):

StimRouter Neuromodulation System K200482

#### IV. Device Description

The StimRouter Neuromodulation System consists of two main parts - the implantable lead, and the external (to the body) accessories for the StimRouter include a clinician programmer with software (CPS), a disposable hydrogel electrode patch, an external pulse transmitter, an external pulse transmitter stimulation tester and a device used by the patient to wirelessly control the external pulse transmitter. The StimRouter Neuromodulation System is provided with three labeling documents: the Clinician's Guide, the Procedure Manual and the User's Guide.

The Bioness StimRouter Neuromodulation System is intended to provide electrical stimulation via an implanted lead to a target peripheral nerve, for aid in the management of severe, intractable, chronic pain of peripheral nerve origin in adults, as an adjunct to other modes of therapy (e.g. medications). The StimRouter is not intended to treat pain in the craniofacial region.

The complete StimRouter System consists of three kits: a Lead and Lead Introducer Kit, a Clinician Kit and User Kit. The Lead Kit contains the StimRouter implantable multielectrode lead with integrated receiver, used for peripheral nerve stimulation. The Lead receives an electrical signal transmitted transcutaneously by the external pulse transmitter which is mounted on an electrode patch on the skin and delivers that electrical signal down the lead's length to a target peripheral nerve. The Lead is supplied in Lead Loader that is used during intraoperative testing of the lead and to verify proper placement during implantation.

The Lead and Lead Introducer Kit consists of two stimulation probes, two stimulation cables, and introducer set, a lead adapter, a Tunneling Needle, and a Tunneling Needle Stylet. The included tools and components allow for insertion of the StimRouter Lead and confirmation of optimal location of the stimulation electrode contacts of the StimRouter Lead.

The Clinician Kit is used for the programming of the external pulse transmitter. The components of the Clinician Kit are a tablet PC with programming software that is capable of connecting to and configuring the external pulse transmitter.

The User Kit contains the patient-use components of the StimRouter System. The components are the External Electric Field Conductor (E-EFC), an external pulse transmitter, with included charger and the StimRouter Electrode Carrying Case. After the E-EFC is programmed, the E-EFC can be connected to the StimRouter Electrode through which it can deliver stimulation transcutaneously to the implanted lead receiver.

#### V. Indications for Use

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Image /page/5/Picture/0 description: The image shows the logo for Bioness. The logo consists of an orange sun-like symbol on the left and the word "Bioness" in gray on the right. There is an orange dot above the "i" in Bioness. There is a registered trademark symbol next to the last "s" in Bioness.

The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.

LiveOn™

#### VI. Comparison of Technological Characteristics

The table below compares the principles of operation and operational/technological characteristics for the subject device and the predicate device. These comparisons confirm that the subject and predicate devices have very similar overall principles of operation and operational/technological characteristics, thereby support the substantial equivalence of the subject device to the predicate. Except for three accessories, the subject device is identical to the predicate. The three accessories, the External Electrical Field Conductor, the MAPP Smartphone Application, and a modified version of the Clinician's Programming Software, are newer versions of three accessories of the predicate, the External Pulse Transmitters, the Patient Programmer, and the original Clinician's Programming Software. These new accessories will replace the accessories in the system. The table below confirms that the three new subject device accessories have equivalent functionality to the predicate's accessories that they will replace.

| | Subject Device (Modified<br>StimRouter) | Predicate (StimRouter<br>cleared in K200482) | Equivalency<br>Assessment |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Bioness Inc. | Bioness Inc. | Same |
| 510(k) number | K211965 | K200482 | - |
| Intended use | The StimRouter<br>Neuromodulation System™<br>is indicated for pain<br>management in adults who<br>have severe intractable<br>chronic pain of peripheral<br>nerve origin, as an adjunct to<br>other modes of therapy (e.g.,<br>medications). The<br>StimRouter is not intended to<br>treat pain in the craniofacial<br>region. | The StimRouter<br>Neuromodulation System™<br>is indicated for pain<br>management in adults who<br>have severe intractable<br>chronic pain of peripheral<br>nerve origin, as an adjunct to<br>other modes of therapy (e.g.,<br>medications). The<br>StimRouter is not intended to<br>treat pain in the craniofacial<br>region. | Same |
| Implantable Lead and Lead Introducer Kit | | | |
| Packaging | No changes | Tray Material: PETG<br>Lid Material: 1073B Tyvek<br>Lid Adhesive: TPT-021C | Same |
| StimRouter Lead | | | |
| StimRouter<br>Lead | No changes | Implanted Lead: Length:<br>15cm, Diameter: 1.2mm,<br>Helical coil design, Anchors,<br>silicone insulator sheathe | Same |
| | Subject Device (Modified<br>StimRouter) | Predicate (StimRouter<br>cleared in K200482) | Equivalency<br>Assessment |
| StimRouter<br>Lead Receiver<br>End | No changes | 12mm receiver electrode,<br>captures portion of signal<br>generated by EPT | Same |
| StimRouter<br>Lead<br>Stimulating<br>End | No changes | 3 cylindrical stimulating<br>electrodes: Materials:<br>Platinum Iridium, Surface<br>Area: $6.3 \text{ mm}^2$ , Max charge<br>per pulse: $3 \mu\text{C}$ , Max charge<br>density: $15.9 \mu\text{C/cm}^2$ | Same |
| Introduction<br>method | No changes | Percutaneous | Same |
| Tunneling<br>Needle and<br>Tunneling<br>Needle Stylet | No changes | Stainless steel hollow needle<br>and solid stylet used to<br>implant receiver end of Lead | Same |
| StimRouter<br>Loader | No changes | Stainless Steel Tube with<br>Reed Connector | Same |
| Stimulation<br>Probe | No changes | Stainless steel wire coated w/<br>titanium nitride and insulated<br>tubing | Same |
| Stimulation<br>Cable | No changes | 2m long Cable for connecting<br>external peripheral nerve<br>stimulator with Stimulation<br>Probe, StimRouter Loader or<br>StimRouter Lead Adaptor | Same |
| Introducer<br>Set | No changes | 11cm long dilator & sheath<br>used for routing stimulation<br>end of Lead from incision to<br>target stimulation point | Same |
| Lead Adaptor | No changes | 5.5 cm stainless steel cylinder<br>which connects to Lead,<br>allowing connection of<br>Stimulation cable | Same |
| Gel<br>Electrodes | No changes | Nonsterile gel electrodes<br>(5cm diameter) used when<br>stimulation applied to<br>Stimulation Probe or<br>Stimulation Lead. Comes<br>with 1.5m long electrode<br>cable | Same |
| | Subject Device (Modified StimRouter) | Predicate (StimRouter cleared in K200482) | Equivalency Assessment |
| External Pulse Generator | No changes | Implantation requires the use of a 510(k) cleared External Pulse Generator (such as Dakmed 750 DPNS, cleared in K791047) to verify correct placement of StimRouter lead | Same |
| | User Kit | | |
| Name | External Electrical Field Conductor (E-EFC) | External Pulse Transmitter (EPT) | Similar. The different product names do not affect safety and effectiveness of intended use. |
| EWD Description | Generates stimulation signals, transmitting them transcutaneously through StimRouter Electrode to StimRouter Lead. Responds to wireless commands MAPP or CPS, or configuration requests from CPS. Snaps onto StimRouter Electrode; contains a rechargeable lithium battery. | Generates stimulation signals, transmitting them transcutaneously through StimRouter Electrode to StimRouter Lead. Responds to wireless commands from Patient Programmer or CPS, or to configuration requests from CPS. Snaps onto StimRouter Electrode; contains a rechargeable lithium battery. | Similar. The E-EFC is substantially equivalent to the EPT for actions including generation of stimulation signals, transmission of signals through Electrode to Lead. Minor differences in hardware are discussed below. |
| EWD Electronics | E-EFC uses a printed circuit board assembly (PCBA) that includes STMicroelectronics STM32L151 Microcontroller and Nordic Semiconductors nRF52832 Bluetooth LE Module. PCBA-based circuitry generates and transmits electrical stimulation current with embedded waveform parameter settings. | EPT uses a PCBA that includes Texas Instrument TI CC2510F32 DS (26 MHz) and a module that allows for encrypted 2.4 GHz wireless communication. PCBA-based circuitry generates and transmits electrical stimulation current with embedded waveform parameter settings. | Similar. The E-EFC PCBA can generate similar electrical stimulation current output as the EPT (symmetrical / asymmetrical, pulse width, pulse frequency, and pulse amplitude). Differences do not affect safety and effectiveness of intended use. |
| | Subject Device (Modified<br>StimRouter) | Predicate (StimRouter<br>cleared in K200482) | Equivalency<br>Assessment |
| EWD<br>Software | STMicroelectronics<br>STM32L151<br>Microcontroller-specific<br>firmware. In addition to<br>controlling the PCBA-based<br>circuitry, the firmware<br>processes and executes<br>wireless commands sent<br>from MAPP and Clinician<br>Programmer and received by<br>the Nordic Semiconductors<br>nRF52832 Bluetooth LE<br>Module | In addition to controlling the<br>PCBA-based circuitry, the<br>Texas Instrument TI<br>CC2510F32 DS-specific<br>firmware processes and<br>executes wireless commands<br>sent from Patient<br>Programmer and Clinician<br>Programmer | Similar. The E-EFC<br>firmware is able to<br>provide substantially<br>equivalent safety,<br>efficacy and<br>functionality as was<br>provided by EPT<br>firmware. |
| EWD Wireless<br>Protocol | BLE wireless protocol | Proprietary 2.4 GHz wireless<br>protocol | Similar. Bluetooth Low<br>Energy (BLE) used by<br>the E-EFC is a widely<br>adopted wireless<br>protocol that can use the<br>2.4 GHz radio<br>frequency and can<br>provide encryption of<br>transmitted data. The<br>proprietary 2.4 GHz<br>protocol of the EPT was<br>written in-house and<br>also provides<br>encryption of<br>transmitted data. |
| EWD Wireless<br>Control and<br>Programming | 2.4 GHz BLE<br>communication used for<br>control of E-EFC by<br>Wireless Remote (MAPP)<br>and control and<br>programming of E-EFC by<br>CPS. | Proprietary 2.4 GHz RF<br>communication used for<br>control of EPT by Wireless<br>Remote (Patient<br>Programmer) and control and<br>programming of EPT by<br>Clinician Programmer<br>Software (CPS) | Similar. The<br>functionality of the EPT<br>(control by wireless<br>remote and control and<br>programming by CPS)<br>has been duplicated in<br>the E-EFC using BLE.<br>The differences do not<br>affect safety and<br>effectiveness of<br>intended use. |
| EWD<br>Electrical<br>Signal<br>Transmitter | E-EFC has PCBA-based<br>circuitry that is functionally<br>equivalent to that of the EPT | EPT has PCBA-based<br>circuitry that generates and<br>transmits the therapeutic<br>electrical signal | Similar. The E-EFC<br>circuitry is functionally<br>equivalent to the EPT<br>circuitry. The<br>differences do not affect<br>safety and effectiveness<br>of intended use. |
| | Subject Device (Modified<br>StimRouter) | Predicate (StimRouter<br>cleared in K200482) | Equivalency<br>Assessment |
| EWD Charger<br>Port | E-EFC uses USB-C charging<br>port | EPT uses Barrel Charging<br>port | Similar. The USB-C-<br>type charging port is<br>functionally equivalent<br>to the EPT barrel port.<br>The differences do not<br>affect safety and<br>effectiveness of<br>intended use. |
| EWD Built-in<br>Control<br>Interface | E-EFC has integrated controls<br>(buttons) that allow the user to<br>turn the device on/off, turn the<br>stimulation on/off, increase or<br>decrease therapy levels. | EPT has no onboard buttons<br>for controlling EPT. | Similar. With the<br>exception of the On/Off<br>button, all other<br>functions provided by<br>the E-EFC integrated<br>button controls were<br>previously provided by<br>the EPT's Patient<br>Programmer. Therefore,<br>the addition of<br>integrated button<br>controls does not affect<br>safety and effectiveness<br>of intended use |
| EWD Status<br>Indicators | E-EFC has an LED built into<br>one of the multi-functional<br>built-in buttons. The LED can<br>indicate charging, standby<br>mode, stimulation mode, low<br>battery, error, action required<br>and pairing mode. | EPT has an integrated LED<br>indicator to indicate when<br>charging is occurring. | Similar. The new<br>functions of the E-EFC<br>were previously<br>provided by the Patient<br>Programmer. Therefore,<br>these differences do not<br>affect safety and<br>effectiveness of<br>intended use |
| EWD<br>Enclosure:<br>Externally<br>Contacting<br>Materials | E-EFC:<br>Housing: TritanTM<br>Copolyester MX731<br>Button overlay: Polycarbonate<br>polyform<br>Snap connector: CDA 260<br>Brass 200 Series S.S | ABS/PC-PBT | Similar. As with the<br>EPT ABS/PC-PBT<br>externally contacting<br>enclosure material, the<br>E-EFC enclosure<br>material was confirmed<br>to be biocompatible for<br>the type and duration of<br>contact as per ISO<br>10993-1. |
| EWD<br>Enclosure:<br>Size and<br>Weight | E-EFC: 5.7 x 3.7 x 1.2 cm,<br>28g | EPT: 5.7 x 3.2 x 1.2 cm, 20g | Similar. The E-EFC is<br>slightly larger and<br>slightly heavier than the<br>EPT, but the differences<br>do not affect safety and<br>effectiveness of<br>intended use. |
| | Subject Device (Modified<br>StimRouter) | Predicate (StimRouter<br>cleared in K200482) | Equivalency<br>Assessment |
| EWD Delivery<br>of Energy | E-EFC delivers<br>transcutaneous electrical<br>pulses via hydrogel patch<br>attached to the skin over the<br>implanted receiver. | EPT delivers transcutaneous<br>electrical pulses via hydrogel<br>patch attached to the skin<br>over the implanted receiver. | Same. The delivery of<br>energy remains<br>unchanged. |
| EWD<br>Stimulation | E-EFC Max output: 30mA<br>Monopolar, Biphasic, Charge<br>Balanced,<br>Pulse Freq: 1-200 Hz,<br>Max Compliance Voltage:<br>130V,<br>Charge per phase limit:15 µC<br>Ramp Up/Down feature<br>Amplitude at Lead: 0-5mA<br>(20% max pick-up ratio)<br>Stimulation Signal:<br>Monopolar | EPT Max output: 30mA<br>Monopolar, Biphasic, Charge<br>Balanced,<br>Pulse Freq: 1-200 Hz,<br>Max Compliance Voltage:<br>100V,<br>Charge per phase limit:15 µC<br>Ramp Up/Down feature<br>Amplitude at Lead: 0-5mA<br>(20% max pick-up ratio)<br>Stimulation Signal:<br>Monopolar | Similar<br>E-EFC max compliance<br>voltage increased to<br>130V.<br>Since both the EPT and<br>E-EFC are current<br>controlled stimulators,<br>the maximal delivered<br>current or other<br>stimulation parameters<br>did not change. Increase<br>in max compliance<br>voltage allows delivery<br>of the required current<br>into higher impedance,<br>thus providing the<br>therapy to a wider range<br>of patient skin<br>impedances. This<br>difference in hardware<br>does not affect safety<br>and effectiveness of the<br>intended use. |
| | Su…