Heat Pain Pro

K160115 · Omron Healthcare, Inc. · NUH · Jun 3, 2016 · Neurology

Device Facts

• Record ID: K160115
• Device Name: Heat Pain Pro
• Applicant: Omron Healthcare, Inc.
• Product Code: NUH · Neurology
• Decision Date: Jun 3, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Omron Heat Pain Pro is intended for: The relief of pain associated with sore or aching, muscles of the lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities. Environments of Use: Clinics, hospital and home environments Patient Population: Adult

Device Story

Heat Pain Pro is a battery-operated OTC TENS device providing electrical stimulation and superficial heat. Inputs: user-selected therapy modes via device controls. Operation: microprocessor-controlled waveform generation; delivers TENS or heat (never simultaneously) via electrode pads with integrated resistive heating elements. Output: electrical pulses for pain relief and warming sensation. Used in clinics, hospitals, or home by patients. Healthcare providers use output to manage muscle pain; device benefits patients through non-pharmacological pain relief. Device includes internal lithium-ion battery, rechargeable via external power supply.

Clinical Evidence

No clinical testing was performed. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (AAMI/ANSI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), and performance testing of waveforms, controls, and indicators. Usability testing was conducted for the OTC lay user population.

Technological Characteristics

Battery-powered (Li-ion) TENS and superficial heat device. Patient-contacting materials: PM-GELs. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11. Regulated current output; microprocessor-controlled. Dimensions: 71x165x30.5mm. Weight: ~200g. Connectivity: external power input for charging only; no data connectivity.

Indications for Use

Indicated for adult patients for relief of pain in lower back, arms, legs, shoulder, or foot due to exercise or household strain. Contraindicated for patients with cardiac pacemakers, implanted defibrillators, or other implanted metallic or electronic devices.

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

• Omron PM3032 (K141978)

Reference Devices

• ezFit Technology ezFit Digital Heating TENS (K070299)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, with three overlapping profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 3, 2016

Omron Healthcare, Inc. % Paul Dryden Consultant Promedic. Inc. 24301 Woodsage Dr. Bonita Springs, Florida 34134

Re: K160115

Trade/Device Name: Heat Pain Pro Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: May 2, 2016 Received: May 3, 2016

Dear Paul Dryden:

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. The general controls provisions of the Act include requirements for annual registration. Isting 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Michael J.Hoffmann -A

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known)

K160115

Device Name

Heat Pain Pro

Indications for Use (Describe)

The Omron Heat Pain Pro is intended for:

The relief of pain associated with sore or aching, muscles of the lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities.

Environments of Use: Clinics, hospital and home environments

Patient Population: Adult

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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FORM FDA 3881 (8/14

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#### 510(k) Summary Page 1 of 9 6/3/2016

| Omron Healthcare, Inc. | |
|----------------------------------------|-------------------------------------------------------------------------------------|
| 1925 West Field Court | Tel - 847-247-5626 |
| Lake Forest, IL 60045 USA | Fax - 847-680-6269 |
| Official Contact: | Renee Thornborough – Director QA/RA |
| Proprietary or Trade Name: | Heat Pain Pro |
| Common/Usual Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Classification Name/Code: | 21CFR 882.5890 NUH - stimulator, nerve, transcutaneous, over-the-counter |
| Device Name: | Heat Pain Pro |
| Predicate Device:<br>Reference Device: | K141978 - Omron - PM3032<br>K070299 – ezFit Technology – ezFit Digital Heating TENS |

#### Device Description:

The Heat Pain Pro is a small battery operated OTC device that provides a combination of transcutaneous electrical nerve stimulation (TENS) for pain relief and superficial heat for a warming sensation. It delivers TENS only or alternating combinations of TENS and heat. TENS and heat are never applied at the same time. The device can connect to a specified external IEC 60601-1 compliant power supply for charging of the internal lithium ion battery. The device complies with AAMI/ ANSI/ES60601-1, IEC 60601-1-2 and IEC 60601-2-10.

Stimulations from the device are intended for application to the following areas: lower back, arms, legs, shoulder or foot. Software controls all controls and indicators. Software controls waveform characteristics.

The accessories include: An external power adaptor, an electrode cord / cable attached to electrodes pads and a Pad holder for storage. The electrode pads Omron "HV-PAD with PMGEL" allow for stimulation and have resistive elements to provide heat which is powered by the device.

The device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is lithium ion and is not user serviceable or accessible. The only external connections on the device are the power input and the electrode connector there is no connection to any other device.

#### Intended User OTC

#### Indications for Use:

The Heat Pain Pro is intended for:

The relief of pain associated with sore or aching, muscles of the lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities.

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#### 510(k) Summary Page 2 of 9 6/3/2016

Environments of Use: Clinics, hospital and home environments Patient Population: Adult

#### Contraindications:

Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death.

### Predicate Device Comparison:

The Omron Heat Pain Pro is compared to the predicates in the device comparison tables below.

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# 510(k) Summary Page 3 of 9
6/3/2016

| | Table 1 Device Comparison | |
|--|---------------------------|--|
| | | |

| | | Proposed<br>Omron Heat Pain Pro | Predicate<br>Omron<br>PM 3032<br>K141978 |
|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | | | |
| Indications for Use | | The Omron Heat Pain Pro is<br>intended for:<br><br>The relief of pain associated<br>with sore or aching, muscles of<br>the lower back, arms, legs,<br>shoulder, or foot due to strain<br>from exercise or normal<br>household work activities.<br><br>Environments of Use: Clinics,<br>hospital and home environments<br><br>Patient Population: Adult | This device is intended for<br>the relief of pain associated<br>with sore or aching, muscles<br>of the<br>lower back, arms, legs,<br>shoulder or foot due to<br>strain from exercise or<br>normal household and work<br>activities. |
| Over-the-Counter (OTC) | | Yes | Yes |
| Power Source(s) | | External supply Lithium-ion<br>battery | AAA alkaline batteries x 2 |
| - Method of Line Current Isolation | | N.A.(internal power source) | N.A.(internal power source) |
| - Patient Leakage Current | | --- | --- |
| - Normal Condition (uA) | | 1 | 1 |
| - Single Fault Condition (uA) | | 5.52 max | 8.9 max |
| Average DC current through electrodes<br>when device is on but no pulse are<br>being applied (uA) | | 0 (uA) | 0 (uA) |
| Number of output Modes | | -3 Therapies<br>(2 TENS with HEAT<br>combination therapies and 1<br>TENS therapy)<br><br>-9 TENS Stimulation Modes<br><br>-2 Heat Level Settings | 9 TENS output Modes |
| Number of output<br>channels | Synchronous<br>or Alternating | 1 ch | 1 ch |
| | Method of<br>Channel<br>Isolation | None | None |
| Regulated Current or Regulated Voltage | | Regulated Current | Regulated Current |
| Software/Firmware/Microprocessor<br>Control? | | Microprocessor | Microprocessor |
| Automatic Overload Trip? | | No | No |
| Automatic No-Load Trip? | | Yes | Yes |
| Automatic shut Off? | | Yes | Yes |
| User over ride control? | | User activated On/Off | User activated On/Off |
| Indication display | | Yes | Yes |
| Feature | Proposed<br>Omron Heat Pain Pro | Predicate<br>Omron<br>PM 3032<br>K141978 | |
| | Low Battery? | Yes | Yes |
| | Voltage /<br>Current<br>Level? | Yes | Yes |
| Timer Range (minutes) | 30 | 15 | |
| Compliance with Voluntary standards? | ES60601-1, IEC60601-1-2,<br>IEC60601-2-10, IEC 60601-1-<br>11 - same as PM3032 –<br>K141978 | ES60601-1, IEC60601-1-2,<br>IEC60601-2-10, IEC 60601-<br>1-11 | |
| Compliance with 21 CFR 898? | Yes | Yes | |
| Weight | Approx. 200g (incl. batteries) | Approx. 100g (incl.<br>batteries) | |
| Dimensions (W x H x D) | 71(W)x165(H)x30.5(D)mm | 52(W)x112(H)x25(D)mm | |
| Operating and Storage Temperature,<br>Humidity | Operating Temperature,<br>10 to 40°C<br>30 to 80 %RH<br>700 to 1060 hPa<br>Storage Temperature,<br>0 to 40°C<br>30 to 80 %RH<br>700 to 1060 hPa | 10 to 40°C<br>30 to 80 % RH | |
| Transportation Temperature,<br>Humidity, Air Pressure | -20 to 60°C<br>10 to 95% RH,<br>700 to 1060 hPa | -20 to 60°C<br>10 to 95% RH,<br>700 to 1060 hPa | |
| Electrode style | PMGEL<br>Reusable | Long Life Pads<br>Reusable | |
| Patient contacting accessory | Electrode | Electrode | |

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#### 510(k) Summary Page 4 of 9 6/3/2016

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#### 510(k) Summary Page 5 of 9 6/3/2016

#### Table 2 Comparison to Reference Device - K070299 ezFit

| Feature | Proposed<br>Omron Heat Pain Pro | Reference<br>ezFit Technology<br>ezFit - K070299 |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Omron Heat Pain Pro is intended<br>for:<br>The relief of pain associated with sore or<br>aching, muscles of the lower back, arms,<br>legs, shoulder, or foot due to strain from<br>exercise or normal household work<br>activities.<br>Environments of Use: Clinics, hospital<br>and home environments<br>Patient Population: Adult | For Transcutaneous Electrical Nerve<br>Stimulation, ezFit Digital Heating TENS<br>(Model No.: HR-661/ UC-101) is intended for<br>* Symptomatic relief and management of<br>chronic intractable pain.<br>For powered heating therapy, ezFit Digital<br>Heating TENS (Model No .: HR-661/<br>UC-101) is intended for<br>Temporary relief of minor aches and pains and<br>muscle spasms |
| Compliance with Voluntary standards? | ES60601-1, IEC60601-1-2, IEC60601-2-<br>10, IEC 60601-1-11 | IEC 60601-1, IEC 60601-1-2, ISO 14081 |
| Power Source | AC adaptor / Rechargeable battery<br>(Lithium Ion) | AC adaptor / Rechargeable battery (Ni-H) |
| Functions | TENS and electrical heating via<br>electrode pad | TENS and electrical heating via electrode pad |
| TENS Modes | Nine Modes | Not specified |
| Heating Setting | High and low | Adjustable |
| Heating temperature | High: 43°C maximum<br>Low: 42°C maximum | 36-42°C |

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#### 510(k) Summary Page 6 of 9 6/3/2016

### Discussion of Substantial Equivalence - Differences Between A Legally Marketed Predicate Device:

The Omron Heat Pain Pro is viewed as substantially equivalent to the predicate device because: The Heat Pain Pro uses the exact same technology and has substantially equivalent indications for use. The differences that exist between the devices are insignificant in the terms of safety or effectiveness.

Indications - These indications are virtually identical to the predicate.

Prescriptive - The Heat Pain Pro and predicate are all OTC.

Design and Technology - The Heat Pain Pro has equivalent design and features when compared to the predicate.

Performance and Specifications – The Heat Pain Pro has equivalent specifications of performance when compared to the predicate.

Compliance with standards -The Heat Pain Pro and predicate comply with the same standards: AAMI ANSI ES60601-1, IEC 60601-1-2. IEC 60601-2-10 and IEC 60601-1-11 for home healthcare.

Materials - The patient contacting materials of the Heat Pain Pro are the PM-GELs. The PM-GELs are constructed of the same materials as the patient contacting portion of the Long Life Pads as cleared in K120516.

Patient Population – The Heat Pain Pro and predicate are indicated for adults

Environment of Use - Clinics, hospital and home environments. Identical to the predicate PM3032

#### Rationale for Reference Device:

The Omron Heat Pain Pro is combines the ability to provide some surface heat as well as TENS. We selected a reference, ezFit Technology ezFit - K070299, as a reference device as it incorporates heat and TENS through the same basic technology. The differences that exist between the devices are related to heat therapy provided by the reference device vs. heat to provide a warming sensation.

Indications - The indications are similar except the reference device provides heat therapy vs. the subject device provide a warming sensation.

Prescriptive - The Heat Pain Pro is OTC vs. the reference is Rx.

Design and Technology - The basic design of providing heat and TENS via a single electrode is similar.

Performance and Specifications - The Heat Pain Pro has similar maximum delivered heat specifications and TENS stimulation.

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#### 510(k) Summary Page 7 of 9 6/3/2016

As indicated in Table 2, one can see that the subject device and reference device are similar and the difference between heat therapy of the reference device and providing a warming sensation for the subject does not raise any new safety concerns. The difference of OTC vs. prescriptive is has been addressed through our risk and hazard analysis and labeling as supported by the usability tested for the lay user population as an OTC device.

### Non-Clinical Testing Summary:

The device has been tested to insure that all requirements have been met, this includes:

- Testing of all controls ●
- Testing of all indicators
- Testing of battery state indicators
- . Testing of waveforms

The device has also been tested to the requirements of the following standards:

- AAMI / ANSI ES60601-1:2005 + A1: 2012 Medical electrical equipment part 1: ● general requirements for basic safety and essential performance
- . IEC 60601-1-2: 2007 Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral standard: Electromagnetic Compatibility - Requirements and Tests
- IEC 60601-1-11: 2015, medical electrical equipment part 1-11: general requirements ● for basic safety and essential performance - collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- . IEC 60601-2-10: 2012 Medical electrical equipment - part 2-10: particular requirements for the basic safety and essential performance of nerve and muscle stimulators

The device has also been tested for drop, vibration and environmental temperature and humidity.

Usability testing was performed.

### Clinical Testing Summary:

No clinical testing was performed

### Substantial Equivalence Conclusion

Omron maintains that the Heat Pain Pro is substantially equivalent to the predicate device in indications for use, patient population, and environment for use, technology characteristics, specifications / performance and compliance with international standards.

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# 510(k) Summary

# Page 8 of 9

# 6/3/2016

| Parameter | Subject | PM3032 | Subject | PM3032 | Subject | PM3032 | Subject | PM3032 | |
|-------------------------------------------------|---------------------------------|-------------|-------------|-------------|---------------|-------------|-------------|-------------|---------|
| Mode of Program Name | TAP | TAP | KNEAD | KNEAD | RUB | RUB | ARM | ARM | |
| Waveform | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | |
| Shape | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | |
| Maximum Output Voltage [V] | @500Ω | 67.2 | 66.3 | 40.7 | 51.1 | 37.3 | 42.3 | 67.1 | 66.3 |
| | @2KΩ | 85.6 | 87.6 | 56.6 | 67.9 | 51.2 | 55.9 | 86.0 | 87.9 |
| | @10kΩ | 95.9 | 95.9 | 62.4 | 73.9 | 56.7 | 59.9 | 95.7 | 95.9 |
| Maximum Output Current [mA] | @500Ω | 134.4 | 132.6 | 81.4 | 102.2 | 74.6 | 84.6 | 134.2 | 132.6 |
| | @2KΩ | 42.8 | 43.8 | 28.3 | 34.0 | 25.6 | 28.0 | 45.0 | 44.0 |
| | @10KΩ | 9.6 | 9.6 | 6.2 | 7.4 | 5.7 | 6.0 | 9.6 | 9.6 |
| Duration of primary phase [usec] | | 32 | 32 | 32 | 32 | 32 | 32 | 32 | 32 |
| Pulse Duration [usec] | | 96 | 100 | 96 | 150 | 96 | 150 | 96 | 100 |
| Frequency [Hz] | | 1 - 20.13 | 1 - 15.43 | 51.65 | 25.28 - 79.22 | 99 | 84.86 - 132 | 2 - 51.65 | 1 - 132 |
| For multiphasic waveforms | Symmetrical phases | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| only: | Phase Duration | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Net Charge(µC per pulse) (@500Ω) [uC] * | | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Maximum Phase Charge (@500Ω) [µC] | | 4.30 | 4.24 | 2.60 | 3.27 | 2.39 | 2.71 | 4.29 | 4.24 |
| Maximum Current Density (@500Ω) [mA/cm²] | | 8.43 | 3.03 | 5.10 | 2.33 | 4.68 | 1.93 | 8.41 | 3.03 |
| Maximum Current Density (@500Ω) [mA/cm²] r.m.s. | | 0.08 | 0.03 | 0.36 | 0.14 | 0.46 | 0.22 | 0.12 | 0.03 |
| Maximum Average Power Density (@500Ω) [W/cm²] | | 5.219E-09 | 0.00017 | 5.107E-06 | 0.00020 | 1.576E-05 | 0.00039 | 2.081E-08 | 0.00060 |
| Burst Mode | (a) Pulses per burst | 60.4 | 46 | 222.1 | 71 | 544.5 | 118 | 60.4 | 23 |
| | (b) Bursts per second | 0.32 | 0.33 | 0.12 | 0.59 | 0.09 | 0.59 | 0.32 | 1.00 |
| | **(c) Burst duration | 3.10 | 3.00 | 8.60 | 8.50 | 11.00 | 17.00 | 3.10 | 8.00 |
| | (d) Duty cycle: Line(b)xLine(c) | 1.00 | 1.00 | 1.00 | 5.00 | 1.00 | 10.00 | 1.00 | 8.00 |
| ON Time (seconds) | | 3.00 | 3.00 | 7.80 | 0.90 | 10.50 | 0.90 | 3.00 | 0.30 |
| OFF Time (seconds) | | 0.10 | 0.00 | 0.80 | 0.80 | 0.50 | 0.80 | 0.10 | 0.70 |
| Additional Features | | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |

Subject device is Heat Pain Pro

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# 510(k) Summary

# Page 9 of 9

6/3/2016

| Parameter | | Subject | PM3032 | Subject | PM3032 | Subject | PM3032 | Subject | PM3032 | Subject | PM3032 |
|-------------------------------------------------|---------------------------------|-------------|-------------|-------------|-------------|-------------|-------------|-------------|---------------|-------------|-------------|
| Mode of Program Name | | LBACK | LBACK | LEG | LEG | FOOT | FOOT | JOINT | JOINT | SHLDR | SHLDR |
| Waveform | | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic | Biphasic |
| Shape | | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular | Rectangular |
| Maximum Output Voltage [V] | @500Ω | 67.1 | 66.3 | 66.4 | 66.3 | 66.9 | 66.3 | 40.3 | 66.3 | 67.1 | 66.3 |
| | @2kΩ | 84.0 | 87.9 | 85.5 | 87.9 | 85.9 | 87.9 | 56.8 | 87.9 | 84.8 | 87.9 |
| | @10kΩ | 94.0 | 95.9 | 95.5 | 95.9 | 95.8 | 95.9 | 63.1 | 95.9 | 95.4 | 95.9 |
| Maximum Output Current [mA] | @500Ω | 134.2 | 132.6 | 132.8 | 132.6 | 133.8 | 132.6 | 80.6 | 132.6 | 134.2 | 132.6 |
| | @2kΩ | 42.0 | 44.0 | 42.8 | 44.0 | 43.0 | 44.0 | 28.4 | 44.0 | 42.4 | 44.0 |
| | @10kΩ | 9.4 | 9.6 | 9.6 | 9.6 | 9.6 | 9.6 | 6.3 | 9.6 | 9.5 | 9.6 |
| Duration of primary phase [usec] | | 32 | 32 | 32 | 32 | 32 | 32 | 32 | 32 | 32 | 32 |
| Pulse Duration [usec] | | 96 | 150 | 96 | 100 | 96 | 100 | 96 | 100 | 96 | 100 |
| Frequency [Hz] | | 2 - 108 | 1 - 237.6 | 2 - 51.65 | 1 - 19.16 | 2 -11 | 1 - 19.16 | 42.43 - 108 | 42.43 - 237.6 | 1 - 19 | 1 - 19.16 |
| For multiphasic waveforms<br>only: | Symmetrical phases | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| | Phase Duration | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |
| Net Charge(µC per pulse) (@500Ω) [µC] | | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Maximum Phase Charge (@500Ω) [µC] | | 4.29 | 4.24 | 4.25 | 4.24 | 4.28 | 4.24 | 2.58 | 4.24 | 4.29 | 4.24 |
| Maximum Current Density (@500Ω) [mA/cm2] | | 8.41 | 3.03 | 8.33 | 3.03 | 8.39 | 3.03 | 5.05 | 3.03 | 8.41 | 3.03 |
| Maximum Current Density (@500Ω) [mA/cm2] r.m.s. | | 0.12 | 0.04 | 0.12 | 0.03 | 0.12 | 0.03 | 0.32 | 0.20 | 0.08 | 0.03 |
| Maximum Average Power Density (@500Ω) [W/cm2] | | 2.081E-08 | 0.00015 | 2.038E-08 | 0.00040 | 2.069E-08 | 0.00016 | 3.379E-06 | 0.00015 | 5.203E-09 | 0.00082 |
| Burst Mode | (a) Pulses per burst | 540.0 | 1425 | 258.3 | 57 | 55.0 | 57 | 324.0 | 1425 | 76.0 | 76 |
| | (b) Bursts per second | 0.10 | 0.14 | 0.10 | 0.25 | 0.19 | 0.25 | 0.25 | 0.14 | 0.20 | 0.20 |
| | **(c) Burst duration | 20.00 | 14.00 | 10.00 | 8.00 | 5.20 | 8.00 | 16.00 | 14.00 | 10.00 | 10.00 |
| | (d) Duty cycle: Line(b)xLine(c) | 2.00 | 2.00 | 1.00 | 2.00 | 1.01 | 2.00 | 4.00 | 2.00 | 2.00 | 2.00 |
| ON Time (seconds) | | 20.00 | 6.00 | 9.00 | 3.00 | 5.00 | 3.00 | 11.00 | 6.00 | 8.00 | 4.00 |
| OFF Time (seconds) | | 0.00 | 1.00 | 1.00 | 1.00 | 0.15 | 1.00 | 4.00 | 1.00 | 2.00 | 1.00 |
| Additional Features | | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A | N/A |

Subject device is the Heat Pain Pro