Avid IF2

K183692 · Vision Quest Industries Inc./Dba VQ Orthocare · LIH · Jun 12, 2019 · Neurology

Device Facts

• Record ID: K183692
• Device Name: Avid IF2
• Applicant: Vision Quest Industries Inc./Dba VQ Orthocare
• Product Code: LIH · Neurology
• Decision Date: Jun 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Avid IF2 Interferential Stimulator, Model AV-IF19A, is indicated for use in the following applications: -Symptomatic relief of post-surgical and/or post traumatic acute pain -Symptomatic relief of chronic intractable pain -Relaxation of muscle spasms -Maintaining and increasing range of motion -Increases local blood circulation

Device Story

Avid IF2 is an interferential (IF) stimulator delivering low electrical current via lead wires to skin-surface electrodes. Device uses microcontroller-based architecture with touchscreen LCD and keypad interface. Clinician adjusts operating parameters; end-user selects protocols and amplitude. Device features two internal rechargeable lithium-ion batteries or external power supply. Data can be uploaded via wired or wireless interface. Device performs self-tests for readiness. Output is IF mode only, utilizing two-frequency interference patterns (four-electrode or two-electrode configurations). Benefits include pain relief, muscle spasm reduction, improved range of motion, and increased local circulation. Used in clinical or home settings under physician prescription.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established through comparative waveform analysis, electrical output specifications (current/power density, phase charge), and safety testing (EN60601-1, IEC60601-1-2) against predicate devices.

Technological Characteristics

Molded ABS/PC plastic housing. Microcontroller-based control. Energy source: 2 internal non-removable rechargeable Li-ion batteries or external power supply. Output: IF mode (4000-4240 Hz), symmetrical biphasic square/rectangular waveform. Connectivity: Wired/wireless data upload. Safety: Automatic overload/no-load trip, automatic shut-off, patient override. Complies with 21 CFR 898.

Indications for Use

Indicated for patients requiring symptomatic relief of post-surgical, post-traumatic, or chronic intractable pain; relaxation of muscle spasms; maintenance or increase of range of motion; and increase of local blood circulation.

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

• T.E.A.R. Tech3 by Vision Quest Industries, Inc. (K030507)
• T.E.A.R. Tech3 by Vision Quest Industries, Inc. (K090532)

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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.

June 12, 2019

Vision Quest Industries, Inc. Mohamed Ouerghi Director of QA/RA 1390 Decision Street, Suite A Vista, California 92081

Re: K183692

Trade/Device Name: Avid IF2 Interferential Stimulator, Model AV-IF19A Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: LIH Dated: March 12, 2019 Received: March 14, 2019

Dear Mohamed Ouerghi:

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

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

Sincerely,

for Carlos Pena, PhD, MS Director 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) K183692

Device Name

Avid IF2 Interferential Stimulator, Model AV-IF19A

Indications for Use (Describe)

The Avid IF2 Interferential Stimulator, Model AV-IF19A is indicated for use in the following applications:

- -Symptomatic relief of post-surgical and/or post traumatic acute pain
- -Symptomatic relief of chronic intractable pain

-Relaxation of muscle spasms

-Maintaining and increasing range of motion

-Increases local blood circulation

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|-----------------------------------------------------------|
| <span></span> | |
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) SUMMARY

| 510(k) Owner: | Vision Quest Industries, Inc.<br>18011 Mitchell South,<br>Irvine, CA, 92614 |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mohamed Ouerghi<br>Director of QA/RA<br>Vision Quest Industries, Inc.<br>Phone [phone]<br>Mobile [phone]<br>Fax [phone]<br>[e-mail] |
| Date Summary Prepared: | 12/24/ 2018 |
| Proprietary Name: | Avid IF2 Interferential Stimulator,<br>Model AV-IF19A |
| Device Name and Classification: | Interferential Current Therapy Stimulator, Class II,<br>21 CFR 882.5890, Product Code LIH |
| Predicate Devices: | T.E.A.R. Tech3 by Vision Quest Industries, Inc.<br>K030507 and K090532 |
| Device Description: | The Avid IF2, Model AV-IF19A is an Interferential<br>Stimulator that produces a low electrical current that<br>is transmitted via lead wires to electrodes placed on<br>the skin in the area predetermined by a clinician.<br>Operating parameters can be adjusted throughout<br>their range by a trained clinician but the end-user is<br>limited to protocol selection and amplitude. The user<br>interface consists of an LCD display and a keypad. |
| Statement of Intended Use: | The Avid IF2 Interferential Stimulator, Model AV-<br>IF19A, is indicated for use in the following<br>applications:<br>☐ Symptomatic relief of post-surgical and/or<br>post traumatic acute pain<br>☐ Symptomatic relief of chronic intractable<br>pain<br>☐ Relaxation of muscle spasms<br>☐ Maintaining and increasing range of motion<br>☐ Increases local blood circulation |

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#### Substantial Equivalence

The Avid IF2 is a generation design improvement to the company's previous device, the T.E.A.R. Tech3 IF/Muscle Stimulator. The company's previous models combined many stimulation modes in one device. The Avid IF2 only has the IF mode. Therefore, as far as modes of stimulation is concerned the equivalency will be established by focusing on the IF mode.

#### Indications for Use

The Avid IF2 has the same indications for use as the predicate devices when these are used in IF mode.

### Device Functionality Equivalency

- Like the predicate devices, the new device uses a microcontroller and LCD ● display to create a user friendly interface.
- The Avid IF2 Stimulator is self-contained and includes two non-removable, rechargeable lithium ion batteries and an external power supply like the predicates.
- The Avid IF2 Stimulator also contains a single output jack for both output channels, and a user interface consisting of a touchscreen LCD for improved user experience. The device software contains self-tests for proper function and readiness. The electrodes used for stimulation are the same used with the predicates. The lead wires are of proprietary design.
- The user is able to select presets on the device for the desired treatment and waveform output based upon prescriptions from the treating clinician. This is accomplished by displayed menu items and selection through the device interface. If desired. the user will be able to upload data stored on the device to Vision Quest Industries, Inc. (via wired interface or wirelessly). The device has the ability to move from preset to preset without patient interaction. This allows for easy use of physician prescribed protocols.

#### Device Characteristics and Output Specifications Equivalency

The Avid IF2 only has the IF mode. The first predicate device from Vision Quest Industries, Inc. has three modes of stimulation: High Volt Pulsed Current (HVPC), Interferential (IF), and a Neuromuscular Electrical Stimulation (NMES) mode. The second predicate device from Vision Quest Industries, Inc. has four modes of stimulation: High Volt Pulsed Current (HVPC), Interferential (IF), Neuromuscular Electrical Stimulation (NMES) mode, and Pulsed Direct Current (PDC).

The next two tables compare the Avid IF 2 to its predicates.

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| 510(k) Number | K030507 | K090532 | Unassigned |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Device Name | T.E.A.R. Tech3 | T.E.A.R. Tech3 | Avid IF2 |
| Manufacturer | Vision Quest Industries, Inc. | Vision Quest Industries, Inc. | Vision Quest Industries, Inc. |
| Power Source | 1 battery pack consisting of a<br>Lithium-ion battery or<br>2 battery packs consisting of 3<br>'AA' alkaline cells each or<br>external power supply | 1 battery pack consisting of a<br>Lithium-ion battery or 2<br>battery packs consisting of 3<br>'AA' alkaline cells each or<br>external power supply | 2 internal, non-removable,<br>rechargeable Lithium-ion<br>batteries or external power<br>supply |
| -Method of Line Current<br>Isolation | Use of UL2601-1 approved<br>external power supply | Use of UL2601-1 approved<br>external power supply | Use of UL2601-1 approved<br>external power supply |
| -Patient Leakage Current | | | |
| -Normal Condition<br>(μΑ) | <500 | <500 | <500 |
| -Single fault condition<br>(μΑ) | <500 | <500 | <500 |
| No. of Output Modes | 3 (IF, HVPC, NMES) | 4 (IF,HVPC,NMES, PDC) | 1 (IF) |
| No. of Output Channels | IF Mode - 2<br>IF Mode - 1<br>NMES Mode- 2<br>HVPC Mode- 1 | IF Mode - 2<br>IF Mode - 1<br>NMES Mode - 2<br>HVPC Mode - 1<br>PDC - 2 | IF Mode - 2<br>IF Mode - 1 |
| Synchronous or<br>Alternating | IF - Synchronous<br>NMES - Synchr. Or Alt.<br>HVPC - Synchr. Or Alt. | IF - Synchronous<br>NMES - Synchr. Or Alt.<br>HVPC - Synchr. Or Alt.<br>PDC - Synchronous | IF - Synchronous |
| Method of Channel<br>Isolation | IF - Transformer coupled<br>NMES - Transformer coupled<br>HVPC – N/A | IF - Transformer coupled<br>NMES - Transformer coupled<br>HVPC – N/A<br>PDC - Transformer coupled | IF - Transformer coupled |
| Reciprocal | IF - No<br>NMES - Yes<br>HVPC - Yes | IF – No<br>NMES - Yes<br>HVPC - Yes<br>PDC – No | IF - No |
| Regulated Current or<br>Regulated Voltage | IF - Regulated voltage<br>NMES – Regulated current<br>HVPC - Regulated voltage | IF - Regulated voltage<br>NMES- Regulated current<br>HVPC – Regulated voltage<br>PDC – Regulated current | IF - Regulated voltage |
| Software/Firmware/<br>Microprocessor Control | Microprocessor Control | Microprocessor Control | Microprocessor Control |
| Software Provided | Yes-Embedded Firmware | Yes- Embedded Firmware | Yes- Embedded Firmware |
| Automatic Overload Trip | Yes | Yes | Yes |
| Automatic No-Load Trip | Yes (w/override option) | Yes (w/override option) | Yes (w/override option) |
| Automatic Shut Off | Yes | Yes | Yes |
| Patient Override Control | Yes | Yes | Yes |
| Indicator Display: | | | |
| Unit Functioning | Yes | Yes | Yes |
| On/Off Status | Yes | Yes | Yes |
| Low Battery | Yes | Yes | Yes |
| Device Characteristics Comparison | | | |
| 510(k) Number | K030507 | K090532 | Unassigned |
| Device Name | T.E.A.R. Tech3 | T.E.A.R. Tech3 | Avid IF2 |
| Manufacturer | Vision Quest Industries, Inc. | Vision Quest Industries, Inc. | Vision Quest Industries, Inc. |
| Voltage/Current Level | 5.75V | 5.75V | 6.0V |
| Other | LCD panel displays all<br>parameter settings. | LCD panel displays all<br>parameter settings. | LCD panel displays all<br>parameter settings. |
| Constant Current | IF- No<br>NMES- Yes<br>HVPC- No | IF - No<br>NMES - Yes<br>HVPC - No<br>PDC - Yes | IF – No |
| Constant Voltage | IF- Yes<br>NMES- No<br>HVPC- Yes | IF – Yes<br>NMES - No<br>HVPC - Yes<br>PDC – No | IF - Yes |
| Timer Range (minutes) | | | |
| Timer Settings | 1 min to 24 hours or<br>continuous | 1 min to 24 hours or<br>continuous | 1 min to 24 hours or<br>continuous |
| Compliance with<br>voluntary Standards | Standards-AAMI/ANSI NS4<br>1986 | NA | NA |
| Compliance with<br>EN60601-1 (Safety) | Not Tested | Yes | Yes |
| Compliance with<br>IEC60601-1-2 (EMC) | Not Tested | Yes | Yes |
| Compliance with 21 CFR<br>898 (Mandatory<br>05/09/02) | Yes | Yes | Yes |
| Weight (with batteries) | 10.6 oz. | 10.6 oz. | 6.8 oz. |
| Dimensions (inches) | 5.7 x 3.0 x 1.5 | 5.7 x 3.0 x 1.5 | 4.9 x 2.85 x 1.0 |
| Housing Materials and | Molded ABS/PC plastic | Molded ABS/PC plastic | Molded ABS/PC plastic |
| Construction | housing | housing | housing |

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#### Technical Explanations:

The following device performance description/comparison to predicate devices are provided in accordance with the FDA document "Guidance Document for Powered Muscle Stimulator 510(k)s" Attachment II section 3, issued on June 9, 1999.

The above document also requires some explanations of calculations and modulations - these are provided below.

#### Interference Pattern

The interference pattern is created using two different frequencies. When the four electrode stimulation is selected two separate frequencies are provided on the two electrode pairs.

Interference occurs at the patient. When two electrodes stimulation is selected the two frequencies are combined inside the device and the interference pattern is delivered via the one electrode pair.

#### Current Density

Current density is calculated using 2 different electrode sizes. A 2" round electrode equal to 20.27 sq. cm and a 2" x 1.25" rectangular electrode is equal to 16.13 sq. cm. This second electrode is used in the Limited mode output where amplitude is limited to 60% of full power.

In the IF mode current density is the pulsed current over the electrode area. Each phase is 50% of the pulse thus the average is given as half.

#### Power Density

Power density is calculated in a similar manner to current density except that the peak phase power density is the max voltage times the max current.

#### Maximum Phase Charge

In the IF mode, charge (Q) can be calculated as follows:

(Peak voltage/load) X duration of pulse

#### Waveform Drawings Explanations

(Drawings are provided on following pages)

The waveform drawings are provided in accordance with the "Guidance Document for Powered Muscle Stimulator 510(k) s".

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#### Waveform Drawings Explanations

The waveform drawings are provided in accordance with the "Guidance Document for Powered Muscle Stimulator 510(k) s".

#### Waveform Drawing 1

Figure 1 This drawing shows the output waveform in the IF stimulation mode. Waveforms are given with purely resistive loads of 500 Ohms, 2000 Ohms, and 10,000 Ohms as required.

Image /page/8/Figure/4 description: Figure 1 shows a graph of amplitude in volts versus time in microseconds. There are three different loads plotted on the graph: 500 Ohms, 2000 Ohms, and 10000 Ohms. The amplitude oscillates between approximately 25 volts and -25 volts. The time ranges from 0 to 450 microseconds.

#### Waveform Drawing 2

Figure 1 Modality = IF Mode = 6/6 This drawing represents the frequency of a series of pulses when the device is in the IF mode with frequency modulation. The modulation parameters are six second ramping between the preset frequencies.

When the device is turned on pulses begin at 60% of the user selected frequency (4000Hz plus beat frequency) over a six second period, ramp up to 160% of the selected frequency. Over the next six second period the frequency ramps down to 60% of the setting again and the cycle starts over.

Figure 2 Modality = IF Mode = 6|6 This drawing represent the frequency of a series of pulses when the device is in the IF mode with frequency modulation. The modulation parameters are six seconds, abruptly changing between the preset frequencies.

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When the device is turned on pulses begin at 60% of the user selected frequency (4000Hz plus beat frequency) over a six second period, instantly change to 160% of the selected frequency for six seconds. The frequency then instantly decreases down to 60% of the setting again and the cycle starts over.

Image /page/9/Figure/1 description: This image shows two waveform drawings, labeled as Figure 1 and Figure 2. Figure 1 shows a triangular waveform, while Figure 2 shows a square waveform. Both figures have a y-axis labeled "Freq." with values of "160% of User Setting", "User Setting", and "60% of User Setting". The x-axis is labeled "time (each hash mark = 1 second)".

#### Waveform Description

The waveforms from the Avid IF2 are the same as the predicate devices. A description of the waveforms is provided below in table format allowing comparison of measured values. For a visual comparison, scope traces of all three devices are also provided below.

Note that the scope traces of all three devices show a slight improvement with each generation; cleaner wave forms and less voltage variation over load.

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| Output Specifications Comparison | | | |
|------------------------------------------------|---------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| 510(k) Number | K030507 | K090532 | Unassigned |
| Device Name | T.E.A.R. Tech3 | T.E.A.R. Tech3 | Avid IF2 |
| Manufacturer | Vision Quest Industries, Inc. | Vision Quest Industries, Inc. | Vision Quest Industries, Inc. |
| Waveform | IF- Sym. Biphasic NMES-<br>Sym/Asym. Biphasic HVPC-<br>Twin peak pulsed<br>monophasic | IF - Sym. Biphasic<br>NMES - Sym/Asym. Biphasic<br>HVPC - Twin peak pulsed<br>monophasic<br>PDC - Symmetrical biphasic<br>and unbalanced triphasic | IF - Sym. Biphasic |
| Max. Output<br>Current (500<br>Ohm Load) | IF Mode- 50mA ±10%<br>NMES Mode- 100mA ±10%<br>HVPC-.66A ±10% | IF Mode- 50mA+/- 10%<br>NMES Mode - 100mA<br>+/- 10%<br>HVPC-.66A+/- 10%<br>PDC-100mA | IF Mode - 50mA+/- 10% |
| Max. Output<br>Voltage (500<br>Ohm Load) | IF- 25V ± 10%<br>NMES- 50V ±10%<br>HVPC 330V ±10% | IF- 25V +/- 10%<br>NMES- 50V +/- 10%<br>HVPC- 330V +/- 10%<br>PDC - 50V | IF- 25V +/- 10% |
| Shape | IF- Square or rectangular<br>NMES- Rectangular wave<br>HVPC- Dual exponential spike | IF - Square or rectangular<br>NMES - Rectangular wave<br>HVPC - Dual exponential<br>spike<br>PDC - Rectangular wave | IF - Square or rectangular |
| Symmetry | IF- Symmetrical<br>NMES- Symmetrical or<br>Asymmetrical<br>HVPC - No | IF - Symmetrical<br>NMES - Symmetrical or<br>Asymmetrical<br>HVPC - No<br>PDC - Symmetrical and<br>Asymmetrical | IF - Symmetrical |
| Net Phase Charge | IF - 0µC<br>NMES – 0µC<br>HVPC- 8.25µC | IF – 0µC<br>NMES – 0µC<br>HVPC – 8.25μC<br>PDC - Symm. – 0µC<br>Asymm. – 6µС | IF – 0µC |
| Peak Phase<br>Current (500<br>Ohm) | IF-50mA<br>NMES - 100mA<br>HVPC-0.66A | IF - 50mA<br>NMES - 100mA<br>HVPC – 0.66A<br>PDC-100mA | IF - 50mA |
| Peak Phase<br>Voltage (500<br>Ohm) | IF-25V<br>NMES - 50V<br>HVPC-330V | IF - 25V<br>NMES - 50V<br>HVPC - 330V<br>PDC - 50V | IF - 25V |
| Phase Rise Time<br>(500 Ohm,<br>max.width) | IF - < 2µS<br>NMES- <2µS<br>HVPC- <1µS | IF - < 2µS<br>NMES- <2µS<br>HVPC- <1µS<br>PDC - <2µS | IF - < 2µS |
| Phase Decay<br>Time (500 Ohm,<br>max. width) | IF- < 2µS<br>NMES- <2µS<br>HVPC- 27µS | IF- < 2µS<br>NMES- <2µS<br>HVPC- 27µS<br>PDC - <2µS | IF- < 2µS |
| Phase Duration<br>Range (at 50%<br>max. width) | IF - 7µS – 125μS<br>NMES - 30µS – 300μς<br>HVPC-5µS | IF - 7µS – 125μς<br>NMES - 30µS – 300μ<br>HVPC-5µS<br>PDC - 60uS | IF - 7µS – 125μς |
| Output Specifications Comparison | | | |
| 510(k) Number | K030507 | K090532 | Unassigned |
| Device Name | T.E.A.R. Tech3 | T.E.A.R. Tech3 | Avid IF2 |
| Manufacturer | Vision Quest Industries, Inc. | Vision Quest Industries, Inc. | Vision Quest Industries, Inc. |
| Interphase | IF – 0µS | IF – 0µS | IF – 0µS |
| Interval | NMES - 0 - 250µS | NMES - 0 - 250µS | |
| | HVPC - 100 - 300µS | HVPC - 100 - 300µS | |
| | | PDC – 900µS, 1800µS | |
| Frequency Range | IF- 4000 Hz - 4240 Hz | IF- 4000 Hz - 4240 Hz | IF- 4000 Hz - 4240 Hz |
| | NMES - 1-200 Hz | NMES- 1-200 Hz | |
| | HVPC - 1-200 Hz | HVPC - 1-200 Hz | |
| | | PDC - Symm: 278Hz | |
| | | Asymm: 222Hz | |
| Interference | IF - Yes | IF - Yes | IF - Yes |
| Pattern | NMES - No | NMES - No | |
| | HVPC - No | HVPC - No | |
| | | PDC – No | |
| Beat | IF- 1-240 Hz | IF- 1-240 Hz | IF- 1-240 Hz |
| Frequencies | NMES - NA | NMES - NA | |
| | HVPC - NA | HVPC – NA | |
| | | PDC - NA | |
| Burst Mode | No | No | No |
| Current Density | | | |
| Peak (per sq. | IF - 2.47mA | IF – 2.47mA | IF - 2.47mA |
| cm) | NMES - 4.93mA | NMES - 4.93mA | |
| (500 Ohm | HVPC - 65.1mA | HVPC - 65.1mA | |
| Load) | | PDC - 0.98mA | |
| Ave. (per sq. | IF - 1.235mA | IF - 1.235mA | IF - 1.235mA |
| cm) | NMES - 0.295mA | NMES - 0.295mA | |
| (500 Ohm | HVPC - 0.13mA | HVPC - 0.13mA | |
| Load) | | PDC - 0.059mA | |
| Power Density | | | |
| Peak (per sq. | IF - 61.7mW | IF - 61.7mW | IF - 61.7mW |
| cm) | NMES - 247 mW | NMES - 247 mW | |
| (500 Ohm | HVPC – 10.7 W | HVPC - 10.7 W | |
| Load) | | PDC - 49.4mW | |
| Ave. (per sq. | IF - 30.85mW | IF - 30.85mW | IF - 30.85mW |
| cm) | NMES - 14.8 mW | NMES - 14.8 mW | |
| (500 Ohm | HVPC - 21.4 mW | HVPC - 21.4 mW | |
| Load) | | PDC - 2.96mW | |
| Max. Phase | | | |
| Charge | | | |
| 500 Ohms | IF- 6.25µC | IF- 6.25µC | IF- 6.25µC |
| | NMES - 30 µC | NMES - 30 µC | |
| | HVPC- 9.9 µC | HVPC- 9.9 µC | |
| | | PDC - 6µC | |
| 2K Ohms | IF- 1.56 µC | IF- 1.56 µC | IF- 1.56 µC |
| | NMES - 7.5 µC | NMES - 7.5 µC | |
| | HVPC- 1.65 µC | HVPC- 1.65 µC | |
| | | PDC – 1.5µC | |
| 10K Ohms | IF- 0.33 µC | IF- 0.33 µC | IF- 0.33 µC |
| | NMES - 1.5 µC | NMES - 1.5 µC | |
| | HVPC- 0.33 µC | HVPC- 0.33 µC | |
| | | PDC - 0.3µC | |

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Image /page/12/Figure/0 description: The image shows a graph of four electrode stimulation with a 500 Ohm resistive load. The graph shows voltage in DC on the y-axis ranging from -50 to 50, and time in microseconds on the x-axis ranging from -250 to 250. The graph shows a square wave pattern, with the voltage alternating between approximately 20 and -20. There are two yellow markers on the graph, one at approximately (-150, 20) and the other at approximately (0, 20).

Image /page/12/Figure/2 description: The image shows the text "Four Electrode Stimulation, 500 Ohm Resistive Load - Predicate (K090532)". The text describes a type of electrical stimulation using four electrodes and a 500 Ohm resistive load. The term "Predicate" is also included, along with a code or identifier, K090532.

Image /page/12/Figure/3 description: The image shows a graph with voltage on the y-axis and time in microseconds on the x-axis. The voltage ranges from -50 to 50 V, while the time ranges from -250 to 250 microseconds. The graph shows a square wave oscillating between approximately 20 V and -20 V. There are some oscillations at the rising and falling edges of the square wave.

Image /page/12/Figure/5 description: The image shows a graph of four electrode stimulation with a 500 Ohm resistive load. The x-axis represents time in microseconds, ranging from -250 to 250. The y-axis represents voltage in DC, ranging from -50 to 50. The graph shows a square wave pattern, alternating between approximately 20 and -20 volts.

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Image /page/13/Figure/0 description: The image shows a graph of four electrode stimulation with a 200 Ohm resistive load. The x-axis represents time in microseconds, ranging from -250 to 250. The y-axis represents voltage in DC, ranging from -50 to 50. The graph displays a square wave pattern, alternating between approximately 20 and -20 voltage levels.

Image /page/13/Figure/2 description: The image shows the title of a document or presentation. The title reads "Four Electrode Stimulation, 200 Ohm Resistive Load - Predicate (K090532)". The title describes an experiment or setup involving four electrodes and a 200 Ohm resistive load. The term "Predicate" and the code "K090532" may refer to a specific project or experiment identifier.

Image /page/13/Figure/3 description: The image shows a graph with voltage on the y-axis and time on the x-axis. The voltage ranges from -50 to 50 V, and the time ranges from -250 to 250 microseconds. The graph shows a square wave with a high voltage of approximately 20 V and a low voltage of approximately -20 V. The wave oscillates between these two voltages.

Image /page/13/Figure/5 description: The figure shows a graph of four electrode stimulation with a 200 Ohm resistive load. The x-axis represents time in microseconds, ranging from -250 to 250. The y-axis represents voltage in DC, ranging from -50 to 50. The graph shows a square wave pattern, with the voltage alternating between approximately 20 and -20.

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Image /page/14/Figure/0 description: The image shows a graph of four electrode stimulation with a 2000 Ohm resistive load. The x-axis represents time in microseconds, ranging from -250 to 250. The y-axis represents voltage in DC, ranging from -50 to 50. The graph shows a square wave pattern, with the voltage alternating between approximately 25 and -25.

Image /page/14/Figure/2 description: The image shows the text "Four Electrode Stimulation, 2000 Ohm Resistive Load – Predicate (K090532)". The text describes a four-electrode stimulation setup with a 2000 Ohm resistive load. The term "Predicate (K090532)" likely refers to a specific condition or setting within the experiment or system.

Image /page/14/Figure/3 description: The image shows a graph with voltage (V) on the y-axis and time (µs) on the x-axis. The graph displays a square wave oscillating between approximately -25V and +25V. The x-axis ranges from -250 µs to 250 µs, while the y-axis ranges from -50V to 50V. The graph also shows some ringing or overshoot at the transitions of the square wave.

Image /page/14/Figure/5 description: The image shows a graph titled "Four Electrode Stimulation, 2000 Ohm Resistive Load – Predicate (K030507)". The graph shows voltage in DC on the y-axis ranging from -50.0 to 50.0, and time in microseconds on the x-axis ranging from -250.0 to 250.0. The graph shows a square wave pattern, with the voltage alternating between approximately 25 and -25.

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Image /page/15/Figure/0 description: The image shows a graph of two electrode stimulation with a 500 Ohm resistive load. The x-axis represents time in microseconds, ranging from -250 to 250. The y-axis represents voltage in DC, ranging from -50 to 50. The graph shows a series of positive and negative pulses, with the voltage alternating between approximately 20 and -20.

Two Electrode Stimulation, 500 Ohm Resistive Load - Predicate (K090532)

Image /page/15/Figure/3 description: The image shows a graph of voltage in DC as a function of time in microseconds. The voltage ranges from -50 to 50, and the time ranges from -250 to 250. The graph shows a periodic square wave with voltage alternating between approximately 23 and -23.

Image /page/15/Figure/4 description: The image shows a graph of two electrode stimulation with a 500 Ohm resistive load. The x-axis represents time in microseconds, ranging from -250 to 250. The y-axis represents voltage in DC, ranging from -50 to 50. The graph shows a periodic waveform with positive and negative voltage peaks.

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## Substantial Equivalence Summary

Based on the data contained in the previous two tables we conclude that the Avid IF2 is equivalent to its predicates. In addition, it provides cleaner wave forms and less voltage variation over load as shown in the scope traces of all three devices