To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Device Description

The subject device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS), intended for the over-the-counter use to temporarily relieve pain and stimulate muscle in different body areas. The double-channel subject device, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse through the connecting wires and electrode pads to the user's skin for pain relief and muscle stimulation. The electrode pad used consists of gel, carbon film, cloth backing, and electrode connector, which is 510(k)-cleared and biocompatible, According to the need of users, the pulse intensity can be adjustable on the front control panel of the device.

AI/ML Overview

This document describes the 510(k) summary for the IQ Technologies Pro IVs, Pro V, and Pro VI, which are Transcutaneous Electrical Nerve Stimulators (TENS) and Powered Muscle Stimulators (PMS). The core argument for acceptance is substantial equivalence to a previously cleared predicate device (IQ Technologies, K131290), rather than a study proving the device meets strict performance acceptance criteria based on clinical outcomes or diagnostic accuracy. Therefore, the provided information does not contain the typical details of a study involving a test set, ground truth, and expert adjudication as one might see for an AI/ML medical device.

Based on the provided text, here's a description framed within the context of substantial equivalence for this type of device:

Acceptance Criteria and Study for Substantial Equivalence

1. Table of Acceptance Criteria (for Substantial Equivalence) and Reported Device Performance

Instead of explicit performance metrics like sensitivity or specificity, the "acceptance criteria" here are the technical characteristics and intended use being sufficiently similar to the predicate device. The device performance is demonstrated by the comparative table showing these similarities and compliance with relevant safety standards.

Acceptance Criteria (for Substantial Equivalence)	Predicate Device (K131290)	Subject Device (Pro IVs, Pro V, and Pro VI)	Status (Met/Not Met)
Intended Use	Temporary relief of pain associated with sore and aching muscles; stimulate healthy muscles to improve performance.	Temporary relief of pain associated with sore and aching muscles; stimulate healthy muscles to improve performance.	Met (Identical)
Power Source	DC 3.7V Lithium Battery	DC 3.7V Lithium Battery	Met (Identical)
Number of Output Channels	2	2	Met (Identical)
Automatic Overload Trip	No	No	Met (Identical)
Automatic No-Load Trip	No	No	Met (Identical)
Automatic Shut Off	Yes	Yes	Met (Identical)
User Override Control	Yes	Yes	Met (Identical)
Indicator	Yes	Yes	Met (Identical)
Waveform	Pulsed	Pulsed	Met (Identical)
Shape	Rectangular	Rectangular	Met (Identical)
Maximum output voltage (Volts +/- 20%) at 500Ω	64	66	Met (Within expected variation for substantial equivalence)
Maximum output voltage (Volts +/- 20%) at 2KΩ	94.4	100	Met (Within expected variation for substantial equivalence)
Maximum output voltage (Volts +/- 20%) at 10kΩ	129	128	Met (Within expected variation for substantial equivalence)
Maximum output current (mA +/- 20%) at 500Ω	128	132	Met (Within expected variation for substantial equivalence)
Maximum output current (mA +/- 20%) at 2KΩ	47.2	50	Met (Within expected variation for substantial equivalence)
Maximum output current (mA +/- 20%) at 10KΩ	12.9	12.8	Met (Within expected variation for substantial equivalence)
Pulse Width (µSec)	100	100	Met (Identical)
Pulse Period (mSec)	10~840	10~833	Met (Slight variation, deemed substantially equivalent)
Frequency (Hz)	1.2~100	1.2~100	Met (Identical)
Maximum Phase Charge (µC) at 500Ω	16.8	17.3	Met (Within expected variation for substantial equivalence)
Maximum current density (mA/cm²) at 500Ω	3.36	3.3	Met (Within expected variation for substantial equivalence)
Maximum average power density (mW/cm²) at 500Ω	2.11	2.0	Met (Within expected variation for substantial equivalence)
Compliance with Voluntary Standards	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10	Met (Identical standards)
Compliance with 21 CFR 898	Yes	Yes	Met (Identical standard)

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

Test Set: The "test set" in this context refers to the subject device itself and its components undergoing non-clinical testing. There isn't a patient-level "test set" as would be used for an AI/ML algorithm or clinical trial. The testing is performed on the device prototypes/production samples.
Data Provenance: The data provenance is from the manufacturer's non-clinical testing laboratories (implicitly, given compliance with international standards) and appears to be prospective as it involves the testing of the subject's device design. There is no mention of country of origin for the data beyond the standards being international.

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

This type of information is not applicable to this 510(k) submission. The "ground truth" for electrical stimulation devices is based on engineering specifications and compliance with recognized safety and performance standards (e.g., IEC standards). Expert consensus or qualifications of human readers/experts are not relevant for establishing the performance of a TENS/PMS device in this context.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or for establishing ground truth from expert readings (e.g., for imaging studies). For electro-mechanical devices demonstrating substantial equivalence through non-clinical testing, adjudication is not a relevant concept.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not performed. This type of study is typically done for diagnostic devices, especially those involving human interpretation of data (e.g., medical images), to assess reader performance with and without AI assistance. This device is a therapeutic electrical stimulator, not a diagnostic imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not a software algorithm device in the context of AI/ML or diagnostic image analysis. Its performance is inherent to its electromechanical design and functionality, which is evaluated through non-clinical bench testing for compliance with standards.

7. The Type of Ground Truth Used

The "ground truth" here is the established engineering specifications and performance values defined by international consensus standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) and FDA regulations (21 CFR 898). Compliance with these standards indicates safe and effective performance.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of machine learning for this device. The device's design and operating parameters are fixed.

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

Not Applicable. As there is no training set, there is no ground truth to establish for it. The "ground truth" for the device's design and performance is based on established engineering principles and regulatory standards for safety and electrical characteristics.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 26, 2017

IQ Technologies Inc. % Bill Dai Dr Certification LLC 1142 S. Diamond Bar Blvd, #861 Diamond Bar, California 91765

Re: K170659

Trade/Device Name: IQ Technologies Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH;NGX Dated: January 15, 2017 Received: March 3, 2017

Dear Bill Dai:

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, 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 801); medical device reporting (reporting of medical device

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related 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,

William J. Heetderks -S 2017.05.26 11:53:27 -04'00'

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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Indications for Use

510(k) Number (if known) N/A

Device Name IQ Technologies Pro IVs, Pro V, and Pro VI

Indications for Use (Describe)

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

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

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510(k) Summary

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

1. Submitter's Information

Submitter: IQ Technologies Inc. Address: 6672 Spencer St., Ste 800, Las Vegas, NV 89119 Contact Person: Elli Josef Tel: 702-260-8829 Fax: 702-260-8840 Email: elijosef57@gmail.com Date of Preparation: 11/01/2016

2. Correspondent's Information

Dr Certification LLC 1142 S. Diamond Bar Blvd, #861 Diamond bar, CA 91765

3. Subiect Device

Trade/Device Name: IQ Technologies Pro IVs, Pro V, and Pro VI Common Name: Transcutaneous electrical nerve stimulator (TENS) and Powered Muscle Stimulator (PMS) Classification Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter (OTC) Regulation Description: Transcutaneous electrical nerve stimulator for pain relief Regulation Medical Specialty: Neurology Review Panel: Neurology Product Code: NUH, NGX Regulation Number: 21 CFR 882.5890 Device Class: II Use: Over-The-Counter

4. Predicate device

Predicate Device: IQ Technologies 510(k) Number: K131290 Use: Over-The-Counter Submitter: IO Technologies Inc.

5. Description of Subject Device

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6. Intended Use of Subject Device

TENS:

PMS:

It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

7. Summary of Substantial Equivalence

The following table summarizes the comparison between the subject device and predicate devices, indicating the technical characteristics, specifications, and intended use of the subject device are substantially equivalent to those of the predicate devices.

	Predicate Device	Subject Device
510(k) Number	K131290	N/A
Submitter	IQ Technologies Inc.	IQ Technologies Inc.
Device Name	IQ Technologies	IQ Technologies Pro IVs, Pro V, and Pro VI
Intended Use	To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.	To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Power Source	DC 3.7V Lithium Battery	DC 3.7V Lithium Battery
Number of Output Channels	2	2
Automatic Overload Trip	No	No
Automatic No-Load Trip	No	No
Automatic Shut Off	Yes	Yes
User Override Control	Yes	Yes
Indicator	Yes	Yes
Waveform	Pulsed	Pulsed
Shape	Rectangular	Rectangular
Maximum output voltage(Volts +/- 20%) at 500Ω	64	66
Maximum output voltage(Volts +/- 20%) at 2KΩ	94.4	100
Maximum output voltage(Volts +/- 20%) at 10kΩ	129	128

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Maximum output current(mA +/- 20%) at 500Ω	128	132
Maximum output current(mA +/- 20%) at 2KΩ	47.2	50
Maximum output current(mA +/- 20%) at 10KΩ	12.9	12.8
Pulse Width (µSec)	100	100
Pulse period (mSec)	10~840	10~833
Frequency (Hz)	1.2~100	1.2~100
Maximum Phase charge(µC) at 500Ω	16.8	17.3
Maximum current density(mA/cm²) at 500Ω	3.36	3.3
Maximum average powerdensity (mW/cm²) at 500Ω	2.11	2.0
Compliance with VoluntaryStandards	IEC 60601-1, IEC 60601-1-2, IEC60601-2-10	IEC 60601-1, IEC 60601-1-2, IEC60601-2-10
Compliance with 21 CFR898	Yes	Yes

8. Substantial Equivalence

The operational principle of the above predicate devices is to generate small pulses of electrical current and delivers the pulses to the user's skin through adhesive electrode pads such that the underlying nerves and/or muscles are activated.

Identically, the subject device generates small pulses of electrical current and delivers the pulses to the user's skin through adhesive electrode pads such that the underlying nerves and/or muscles are activated.

The comparison between the subject device and predicate devices demonstrates the technical characteristics, specifications, and intended use of the subject device are substantially equivalent to those of the predicate devices.

The differences between the subject device and the predicate devices are insignificant in terms of safety or effectiveness. The verification and validation tests further demonstrate these differences maintain the same safety and effectiveness as those of the 510(k) cleared predicate devices. In other words, these differences do not affect the intended use or alter the fundamental technology of the device. There are no new safety or effectiveness issues concerning the subject device, which offers substantially equivalent technical specifications, features, intended use, and effective results as the predicate devices.

Concerns of the safe and proper use of the electrode pads have been fully addressed by making the use conscious of the proper placement of the electrode pads and appropriate operations of the device through details in the labeling. The electrode pads cleared in K131290 are to be used with the subject device.

9. Non-Clinical Tests Performed

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The subject device does not conduct, nor rely upon, clinical tests to determine substantial equivalence. Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility.

(a) IEC 60601-1 "Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance".
(b) IEC 60601-1-2 "Medical Electrical Equipment Part 1-2: General Requirements for Safety -Collateral standard: Electromagnetic Compatibility - Requirements and Tests".
(c) IEC 60601-2-10 "Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators".

In addition to the compliance of voluntary standards, the verification of software used in the subject device has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The biocompatible electrodes, as the accessory of the subject device, also meet the requirement of safety.

10. Conclusion

The tests performed and the comparison of technical characteristics, specifications, and intended use demonstrate the subject device is substantially equivalent to the predicate device. Therefore, the subject device is as safe and effective as the foregoing identified OTC predicate devices that have been legally marketed in the United States.

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).