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

Here's a breakdown of the acceptance criteria and the study information based on the provided document. It's important to note that this document is a 510(k) summary for a medical device and not a clinical study report for an AI device. Therefore, many of the requested fields related to AI, human readers, and ground truth establishment from a clinical perspective will indicate "Not Applicable" or "Not Provided," as they are not relevant to this type of submission.

Device Name: IQ Technologies (Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS))
510(k) Number: K131290

1. Table of Acceptance Criteria and the Reported Device Performance

This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than setting distinct "acceptance criteria" with specific performance metrics in the way one might for an AI diagnostic algorithm. The acceptance is based on meeting the same safety and effectiveness standards, functional characteristics, and intended use as the predicates, verified through non-clinical testing and comparison of specifications.

Acceptance Criteria Category	Specific Criteria (from Predicate Devices)	Reported Device Performance (IQ Technologies)	Compliance/Comparison
Intended Use (TENS)	Temporary relief of pain associated with sore and aching muscles in shoulder, waist, back, neck, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.	Temporary relief of pain associated with sore and aching muscles in shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.	Substantially Equivalent (Minor difference: no explicit "neck" indication, but covered by general upper body)
Intended Use (PMS)	To stimulate healthy muscles to improve and facilitate muscle performance.	To stimulate healthy muscles to improve and facilitate muscle performance.	Substantially Equivalent
Power Source	DC 3.7V Lithium Battery	DC 3.7V Lithium Battery	Equivalent
Number of Output Channels	2	2	Equivalent
Automatic Overload Trip	No	No	Equivalent
Automatic No-Load Trip	No	No	Equivalent
Automatic Shut Off	Yes	Yes	Equivalent
User Override Control	Yes	Yes	Equivalent
Indicator	Yes	Yes	Equivalent
Waveform	Pulsed	Pulsed	Equivalent
Shape	Rectangular	Rectangular	Equivalent
Maximum output voltage (Volts +/- 20%) at 500Ω	Predicate 1: 62.4Predicate 2: 70	Mode 1: 42Mode 2: 63.2Mode 3: 64Mode 4: 34.4Mode 5: 32Mode 6: Cycles above five modes	Comparable (within similar ranges for different modes)
Maximum output voltage (Volts +/- 20%) at 2KΩ	Predicate 1: 79.2Predicate 2: 90	Mode 1: 80.8Mode 2: 94.4Mode 3: 87.2Mode 4: 68Mode 5: 64Mode 6: Cycles above five modes	Comparable (within similar ranges for different modes)
Maximum output voltage (Volts +/- 20%) at 10kΩ	Predicate 1: 84Predicate 2: 100	Mode 1: 129Mode 2: 129Mode 3: 96.8Mode 4: 128Mode 5: 119Mode 6: Cycles above five modes	Comparable (within similar ranges for different modes)
Maximum output current (mA +/- 20%) at 500Ω	Predicate 1: 124.8Predicate 2: 140	Mode 1: 84Mode 2: 126.4Mode 3: 128Mode 4: 68.8Mode 5: 64Mode 6: Cycles above five modes	Comparable (within similar ranges for different modes)
Maximum output current (mA +/- 20%) at 2KΩ	Predicate 1: 39.6Predicate 2: 45	Mode 1: 40.4Mode 2: 47.2Mode 3: 43.6Mode 4: 34Mode 5: 32Mode 6: Cycles above five modes	Comparable (within similar ranges for different modes)
Maximum output current (mA +/- 20%) at 10KΩ	Predicate 1: 8.4Predicate 2: 10	Mode 1: 12.9Mode 2: 12.9Mode 3: 9.7Mode 4: 12.8Mode 5: 11.9Mode 6: Cycles above five modes	Comparable (within similar ranges for different modes)
Pulse Width (µSec)	Predicate 1: 100Predicate 2: 90	100	Comparable
Pulse period (mSec)	Predicate 1: 16.3~~781Predicate 2: 10~~836	10~840	Comparable
Frequency (Hz)	Predicate 1: 61.3Predicate 2: 100	Mode 1: 69.4Mode 2: 12.3~54.3Mode 3: 1.2Mode 4: 100Mode 5: 100Mode 6: Cycles above five modes	Comparable (within similar ranges for different modes)
Maximum Phase charge (µC) at 500Ω	Predicate 1: 17.9Predicate 2: 15.7	16.8	Comparable
Maximum current density (mA/cm²) at 500Ω	Predicate 1: 9.92Predicate 2: Mode 1: 6.48, Mode 2: 5.6, Mode 3: 7.2, Mode 4: 5.6, Mode 5: 5.6, Mode 6: Cycles above modes	Mode 1: 3.36Mode 2: 5.06Mode 3: 5.12Mode 4: 2.75Mode 5: 2.56Mode 6: Cycles above five modes	Comparable (within similar ranges for different modes)
Maximum average power density (mW/cm²) at 500Ω	Predicate 1: 2.72Predicate 2: Mode 1: 0.52, Mode 2: 0.39, Mode 3: 0.65, Mode 4: 0.39, Mode 5: 0.39, Mode 6: Cycles above modes	Mode 1: 2.11Mode 2: 0.85~3.75Mode 3: 0.08Mode 4: 2.05Mode 5: 1.64Mode 6: Cycles above five modes	Comparable (within similar ranges for different modes)
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	Compliant
Compliance with 21 CFR 898	Yes	Yes	Compliant

Study Information:

This document is a 510(k) Premarket Notification based on non-clinical testing for substantial equivalence to legally marketed predicate devices. It does not describe a clinical study in the traditional sense of evaluating device effectiveness on patients or evaluating an AI algorithm's performance.

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. The "test set" here refers to the actual subject device undergoing engineering and electrical testing, not a dataset of patient cases.
- Data Provenance: Not applicable. The data comes from direct measurements and engineering tests of the device itself.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in the context of an AI device often referring to clinical diagnosis, is not established for this type of non-clinical engineering and electrical performance testing. Compliance with standards and comparison to predicate device specifications are the "ground truth."
Adjudication method for the test set:
- Not applicable. Electrical and mechanical specifications are objectively measured and compared, not subject to expert adjudication.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS), not an AI-powered diagnostic tool. No human reader involvement in performance evaluation.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Partially applicable, but in a different context. The device's electrical and mechanical performance was evaluated in isolation (standalone) during non-clinical testing. It's a hardware device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: Compliance with established industry electrical and safety standards (IEC 60601 series) and direct comparison to the physical and functional specifications of legally marketed predicate devices.
The sample size for the training set:
- Not applicable. This device is not an AI algorithm that requires a training set.
How the ground truth for the training set was established:
- Not applicable. This device is not an AI algorithm that requires a training set.

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.

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

August 6, 2014

IQ Technologies, Inc. Elli Josef 1631 E. Sunset Rd., Ste. C 103 Las Vegas, NV 89119

Re: K131290 Trade/Device Name: IO Technologies Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electric nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH: NGX Dated: June 30, 2014 Received: July 2, 2014

Dear Mr. Josef:

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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,

Felipe Aguel -S

Carlos L. Peña, Ph.D., M.S. for 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) K131290

Device Name IQ Technologies

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Date: 2014.08.06 22:22:02 -04'00'

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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: 1631 E. Sunset Road, C103, Las Vegas, NV 89119 Contact Person: Elli Josef Tel: 702-260-8829 Fax: 702-260-8840 Email: elijosef57@gmail.com Date of Preparation: 04/11/2013

2. Correspondent's Information

Correspondent: IQ Technologies Inc. Address: 1631 E. Sunset Road, C103, Las Vegas, NV 89119 Contact Person: Elli Josef Tel: 702-260-8829 Fax: 702-260-8840 Email: elijosef57@gmail.com

3. Subject Device

Trade/Device Name: IQ Technologies 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: Powered Muscle Stimulator. JO-5C 510(k) Number: K102598 Use: Over-The-Counter Submitter: Hi-Dow International, Inc.

Predicate Device: TENS&PMS 510(k) Number: K121757 Use: Over-The-Counter Submitter: Healthmate International, LLC

5. Description of Subject Device

The subject device is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle

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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.

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.

	Subject Device	Predicate Device	Predicate Device
510(k) Number	K131290	K102598	K121757
Device Name	IQ Technologies	Hi-Dow	HealthmateForever
Intended Use	To be used for temporaryrelief of pain associatedwith sore and achingmuscles in the shoulder,waist, back, upperextremities (arm), andlower extremities (leg)due to strain fromexercise or normalhousehold workactivities.It is intended to be usedto stimulate healthymuscles in order toimprove and facilitatemuscle performance.	To be used fortemporary relief of painassociated with soreand aching muscles inthe shoulder, waist,back, neck, upperextremities (arm), andlower extremities (leg)due to strain fromexercise or normalhousehold workactivities.It is intended to be usedto stimulate healthymuscles in order toimprove and facilitatemuscle performance.	To be used fortemporary relief of painassociated with soreand aching muscles inthe shoulder, waist,back, neck, upperextremities (arm), andlower extremities (leg)due to strain fromexercise or normalhousehold workactivities.It is intended to be usedto stimulate healthymuscles in order toimprove and facilitatemuscle performance.
Power Source	DC 3.7V Lithium Battery	DC 3.7V LithiumBattery	DC 3.7V LithiumBattery
Number of Output Channels	2	2	2

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Automatic Overload Trip	No	No	No
Automatic No-Load Trip	No	No	No
Automatic Shut Off	Yes	Yes	Yes
User Override Control	Yes	Yes	Yes
Indicator	Yes	Yes	Yes
Waveform	Pulsed	Pulsed	Pulsed
Shape	Rectangular	Rectangular	Rectangular
Maximum output voltage(Volts +/- 20%) at 500Ω	Mode 1: 42Mode 2: 63.2Mode 3: 64Mode 4: 34.4Mode 5: 32Mode 6: This mode cycles the above five modes	62.4	70
Maximum output voltage(Volts +/- 20%) at 2KΩ	Mode 1: 80.8Mode 2: 94.4Mode 3: 87.2Mode 4: 68Mode 5: 64Mode 6: This mode cycles the above five modes	79.2	90
Maximum output voltage(Volts +/- 20%) at 10kΩ	Mode 1: 129Mode 2: 129Mode 3: 96.8Mode 4: 128Mode 5: 119Mode 6: This mode cycles the above five modes	84	100
Maximum output current(mA +/- 20%) at 500Ω	Mode 1: 84Mode 2: 126.4Mode 3: 128Mode 4: 68.8Mode 5: 64Mode 6: This mode cycles the above five modes	124.8	140
Maximum output current(mA +/- 20%) at 2KΩ	Mode 1: 40.4Mode 2: 47.2Mode 3: 43.6Mode 4: 34Mode 5: 32Mode 6: This mode cycles the above five modes	39.6	45
Maximum output current(mA +/- 20%) at 10KΩ		8.4	10
Mode 1: 12.9Mode 2: 12.9Mode 3: 9.7Mode 4: 12.8Mode 5: 11.9Mode 6: This mode cycles the above five modes
Pulse Width (µSec)	100	100	90
Pulse period (mSec)	10~840	16.3~781	10~836
Frequency (Hz)	Mode 1: 69.4Mode 2: 12.3~54.3Mode 3: 1.2Mode 4: 100Mode 5: 100Mode 6: This mode cycles the above five modes	61.3	100
Maximum Phase charge(µC) at 500Ω	16.8	17.9	15.7
Maximum current density(mA/cm²) at 500Ω	Mode 1: 3.36Mode 2: 5.06Mode 3: 5.12Mode 4: 2.75Mode 5: 2.56Mode 6: This mode cycles the above five modes	9.92	Mode 1: 6.48Mode 2: 5.6Mode 3: 7.2Mode 4: 5.6Mode 5: 5.6Mode 6: This mode cycles the above modes
Maximum average powerdensity (mW/cm²) at 500Ω	Mode 1: 2.11Mode 2: 0.85~3.75Mode 3: 0.08Mode 4: 2.05Mode 5: 1.64Mode 6: This mode cycles the above five modes	2.72	Mode 1: 0.52Mode 2: 0.39Mode 3: 0.65Mode 4: 0.39Mode 5: 0.39Mode 6: This mode cycles the above modes
Compliance with VoluntaryStandards	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10
Compliance with 21 CFR898	Yes	Yes	Yes

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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.

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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, such the output voltage and current, between the subject device and the predicate devices are insignificant in terms of safety or effectiveness. The verification and validation tests, such as IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10, 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 K090198 are to be used with the subject device.

9. Non-Clinical Tests Performed

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).