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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Heat Pain Pro device:

The provided document is a 510(k) summary for the Omron Heat Pain Pro, a Transcutaneous Electrical Nerve Stimulator (TENS) device with heat for pain relief. The purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" discussed here primarily relate to demonstrating equivalence in performance and safety to the predicate device, not necessarily a pre-defined clinical efficacy target like a reduction in pain scores.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by similarity to the predicate device (Omron PM3032, K141978) and compliance with specific electrical and medical device safety standards. The reported device performance is primarily a comparison of its electrical output parameters to those of the predicate.

Acceptance Criteria (Implicit)	Reported Device Performance (Heat Pain Pro)
Functional Equivalence
Indications for Use equivalent to predicate.	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. (Virtually identical to predicate.)
OTC device.	Yes
Design and Technology equivalent to predicate.	Equivalent design and features compared to the predicate (PM3032). Combines TENS and heat through the same basic technology as reference device (ezFit, K070299).
Patient Population equivalent to predicate.	Adult (Identical to predicate PM3032)
Environment of Use equivalent to predicate.	Clinics, hospital and home environments (Identical to predicate PM3032)
Electrical Performance Equivalence (compared to PM3032)	Parameters are generally very close or within comparable ranges to the PM3032 across various modes (TAP, KNEAD, RUB, ARM, LBACK, LEG, FOOT, JOINT, SHLDR). See detailed tables {10-11} for specific values, including: - Waveform: Biphasic, Rectangular (matches predicate) - Max Output Voltage, Max Output Current across various loads - Duration of primary phase, Pulse Duration, Frequency - Net Charge, Max Phase Charge, Max Current Density, Max Average Power Density - Burst Mode parameters (Pulses per burst, Bursts per second, Burst duration, Duty cycle) - ON Time, OFF Time
Material Equivalence	Patient contacting materials (PM-GELs) constructed of the same materials as the patient contacting portion of the Long Life Pads cleared in K120516.
Safety and Regulatory Compliance
Compliance with AAMI / ANSI ES60601-1	Complies (ES60601-1:2005 + A1: 2012)
Compliance with IEC 60601-1-2 (EMC)	Complies (IEC 60601-1-2: 2007)
Compliance with IEC 60601-1-11 (Home Healthcare)	Complies (IEC 60601-1-11: 2015)
Compliance with IEC 60601-2-10 (Nerve/Muscle Stimulators)	Complies (IEC 60601-2-10: 2012)
Compliance with 21 CFR 898	Yes
Patient Leakage Current within limits.	Normal Condition: 1 uA (matches predicate). Single Fault Condition: 5.52 uA max (predicate: 8.9 uA max - acceptable).
Average DC current through electrodes (no pulse) at 0 uA.	0 uA (matches predicate).
Automatic No-Load Trip feature.	Yes (matches predicate).
Automatic Shut Off feature.	Yes (matches predicate).
Low Battery and Voltage/Current Level Indications.	Yes (matches predicate).
Timer Range (30 mins vs 15 mins for predicate is a difference, but considered insignificant).	30 minutes (Predicate: 15 minutes). The document implicitly accepts this difference as insignificant in terms of safety or effectiveness, likely due to patient safety features like automatic shut-off and user override.
Drop, Vibration, and Environmental Temperature/Humidity testing.	Performed.
Usability testing performed.	Performed (to address OTC use and differences vs. Rx reference device).

2. Sample Size Used for the Test Set and Data Provenance

The submission does not describe a clinical test set from a clinical study. Instead, the "test set" for the non-clinical performance evaluation appears to be the device itself subjected to a series of engineering and electrical tests. The provenance is the manufacturer's internal testing.

Sample Size for Test Set: Not applicable in the context of a clinical test set. Performance was evaluated on the device itself against established electrical and safety standards.
Data Provenance: The data is from non-clinical testing performed by the manufacturer, verifying the device's electrical output characteristics and compliance with standards. It is not patient data or human subject data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. There was no clinical ground truth established for a test set of patient data, as no clinical studies were performed. The "ground truth" for the non-clinical testing was defined by industry-recognized electrical and medical device safety standards and the performance parameters of the predicate device.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No clinical testing was performed." Therefore, no MRMC study was done, and no effect size for human readers with/without AI assistance is provided or applicable.

6. Standalone Performance Study

Yes, in a non-clinical sense. The device's performance was evaluated in a "standalone" fashion by subjecting it to various engineering and electrical tests as described in the "Non-Clinical Testing Summary" (e.g., testing controls, indicators, battery state, waveforms, compliance with standards like ES60601-1). This is performance of the algorithm/device itself in a lab setting, not a standalone clinical performance study on patients.

7. Type of Ground Truth Used

The "ground truth" for the substantial equivalence claim is:

Predicate Device Performance: The electrical output and functional specifications of the legally marketed predicate device (Omron PM3032).
Regulatory Standards: Compliance with recognized medical device safety and electrical performance standards (e.g., AAMI / ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10).
Reference Device Performance: The basic technology and combined TENS+heat capabilities of the ezFit Digital Heating TENS (K070299) as a reference for integrating heat functionality.

8. Sample Size for the Training Set

Not applicable. There is no mention of an algorithm based on machine learning or AI that would require a training set. The device's operation is based on predefined electrical stimulation parameters and heating control.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set for an AI/ML algorithm.

Summary

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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

{1}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:Reference Device:	K141978 - Omron - PM3032K070299 – ezFit Technology – ezFit Digital Heating TENS

Device Description:

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

		ProposedOmron Heat Pain Pro	PredicateOmronPM 3032K141978
Feature
Indications for Use		The Omron Heat Pain Pro isintended for:The relief of pain associatedwith sore or aching, muscles ofthe lower back, arms, legs,shoulder, or foot due to strainfrom exercise or normalhousehold work activities.Environments of Use: Clinics,hospital and home environmentsPatient Population: Adult	This device is intended forthe relief of pain associatedwith sore or aching, musclesof thelower back, arms, legs,shoulder or foot due tostrain from exercise ornormal household and workactivities.
Over-the-Counter (OTC)		Yes	Yes
Power Source(s)		External supply Lithium-ionbattery	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 electrodeswhen device is on but no pulse arebeing applied (uA)		0 (uA)	0 (uA)
Number of output Modes		-3 Therapies(2 TENS with HEATcombination therapies and 1TENS therapy)-9 TENS Stimulation Modes-2 Heat Level Settings	9 TENS output Modes
Number of outputchannels	Synchronousor Alternating	1 ch	1 ch
	Method ofChannelIsolation	None	None
Regulated Current or Regulated Voltage		Regulated Current	Regulated Current
Software/Firmware/MicroprocessorControl?		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	ProposedOmron Heat Pain Pro	PredicateOmronPM 3032K141978
	Low Battery?	Yes	Yes
	Voltage /CurrentLevel?	Yes	Yes
Timer Range (minutes)	30	15
Compliance with Voluntary standards?	ES60601-1, IEC60601-1-2,IEC60601-2-10, IEC 60601-1-11 - same as PM3032 –K141978	ES60601-1, IEC60601-1-2,IEC60601-2-10, IEC 60601-1-11
Compliance with 21 CFR 898?	Yes	Yes
Weight	Approx. 200g (incl. batteries)	Approx. 100g (incl.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,Humidity	Operating Temperature,10 to 40°C30 to 80 %RH700 to 1060 hPaStorage Temperature,0 to 40°C30 to 80 %RH700 to 1060 hPa	10 to 40°C30 to 80 % RH
Transportation Temperature,Humidity, Air Pressure	-20 to 60°C10 to 95% RH,700 to 1060 hPa	-20 to 60°C10 to 95% RH,700 to 1060 hPa
Electrode style	PMGELReusable	Long Life PadsReusable
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	ProposedOmron Heat Pain Pro	ReferenceezFit TechnologyezFit - K070299
Indications for Use	The Omron Heat Pain Pro is intendedfor:The relief of pain associated with sore oraching, muscles of the lower back, arms,legs, shoulder, or foot due to strain fromexercise or normal household workactivities.Environments of Use: Clinics, hospitaland home environmentsPatient Population: Adult	For Transcutaneous Electrical NerveStimulation, ezFit Digital Heating TENS(Model No.: HR-661/ UC-101) is intended for* Symptomatic relief and management ofchronic intractable pain.For powered heating therapy, ezFit DigitalHeating TENS (Model No .: HR-661/UC-101) is intended forTemporary relief of minor aches and pains andmuscle spasms
Compliance with Voluntary standards?	ES60601-1, IEC60601-1-2, IEC60601-2-10, IEC 60601-1-11	IEC 60601-1, IEC 60601-1-2, ISO 14081
Power Source	AC adaptor / Rechargeable battery(Lithium Ion)	AC adaptor / Rechargeable battery (Ni-H)
Functions	TENS and electrical heating viaelectrode 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 maximumLow: 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 waveformsonly:	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

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
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.(b)
Classification. Class II (performance standards).