IQ TECHNOLOGIES

K131290 · Iq Technologies, Inc. · NUH · Aug 6, 2014 · Neurology

Device Facts

• Record ID: K131290
• Device Name: IQ TECHNOLOGIES
• Applicant: Iq Technologies, Inc.
• Product Code: NUH · Neurology
• Decision Date: Aug 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Compact, portable, microprocessor-controlled, double-channel TENS/PMS device; delivers electrical pulses via adhesive electrode pads (gel, carbon film, cloth) to user's skin. User adjusts pulse intensity via front control panel. Used OTC for pain relief and muscle stimulation. Output affects nerves/muscles to provide temporary relief or facilitate performance. Benefits include non-invasive pain management and muscle conditioning.

Clinical Evidence

Bench testing only. No clinical data. Validation performed via electrical safety and electromagnetic compatibility testing (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10) and software verification per FDA guidance.

Technological Characteristics

DC 3.7V Lithium battery-powered; 2-channel output; microprocessor-controlled. Delivers pulsed rectangular waveforms. Pulse width 100µs; frequency 1.2-100Hz. Biocompatible electrode pads (gel/carbon/cloth). Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, and 21 CFR 898.

Indications for Use

Indicated for temporary relief of pain in shoulder, waist, back, upper/lower extremities due to exercise or household strain; also for stimulation of healthy muscles to improve/facilitate muscle performance. OTC use.

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

• Powered Muscle Stimulator, JO-5C (K102598)
• TENS&PMS (K121757)

Reference Devices

• Electrode pads (K090198)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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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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: [phone] Fax: [phone] Email: [e-mail] 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: [phone] Fax: [phone] Email: [e-mail]

#### 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:

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.

# 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 temporary<br>relief of pain associated<br>with sore and aching<br>muscles in the shoulder,<br>waist, back, upper<br>extremities (arm), and<br>lower extremities (leg)<br>due to strain from<br>exercise or normal<br>household work<br>activities.<br>It is intended to be used<br>to stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance. | To be used for<br>temporary relief of pain<br>associated with sore<br>and aching muscles in<br>the shoulder, waist,<br>back, neck, upper<br>extremities (arm), and<br>lower extremities (leg)<br>due to strain from<br>exercise or normal<br>household work<br>activities.<br>It is intended to be used<br>to stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance. | To be used for<br>temporary relief of pain<br>associated with sore<br>and aching muscles in<br>the shoulder, waist,<br>back, neck, upper<br>extremities (arm), and<br>lower extremities (leg)<br>due to strain from<br>exercise or normal<br>household work<br>activities.<br>It is intended to be used<br>to stimulate healthy<br>muscles in order to<br>improve and facilitate<br>muscle performance. |
| Power Source | DC 3.7V Lithium Battery | DC 3.7V Lithium<br>Battery | DC 3.7V Lithium<br>Battery |
| 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<br>(Volts +/- 20%) at 500Ω | Mode 1: 42<br>Mode 2: 63.2<br>Mode 3: 64<br>Mode 4: 34.4<br>Mode 5: 32<br>Mode 6: This mode cycles the above five modes | 62.4 | 70 |
| Maximum output voltage<br>(Volts +/- 20%) at 2KΩ | Mode 1: 80.8<br>Mode 2: 94.4<br>Mode 3: 87.2<br>Mode 4: 68<br>Mode 5: 64<br>Mode 6: This mode cycles the above five modes | 79.2 | 90 |
| Maximum output voltage<br>(Volts +/- 20%) at 10kΩ | Mode 1: 129<br>Mode 2: 129<br>Mode 3: 96.8<br>Mode 4: 128<br>Mode 5: 119<br>Mode 6: This mode cycles the above five modes | 84 | 100 |
| Maximum output current<br>(mA +/- 20%) at 500Ω | Mode 1: 84<br>Mode 2: 126.4<br>Mode 3: 128<br>Mode 4: 68.8<br>Mode 5: 64<br>Mode 6: This mode cycles the above five modes | 124.8 | 140 |
| Maximum output current<br>(mA +/- 20%) at 2KΩ | Mode 1: 40.4<br>Mode 2: 47.2<br>Mode 3: 43.6<br>Mode 4: 34<br>Mode 5: 32<br>Mode 6: This mode cycles the above five modes | 39.6 | 45 |
| Maximum output current<br>(mA +/- 20%) at 10KΩ | | 8.4 | 10 |
| Mode 1: 12.9<br>Mode 2: 12.9<br>Mode 3: 9.7<br>Mode 4: 12.8<br>Mode 5: 11.9<br>Mode 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: 69.4<br>Mode 2: 12.3~54.3<br>Mode 3: 1.2<br>Mode 4: 100<br>Mode 5: 100<br>Mode 6: This mode cycles the above five modes | 61.3 | 100 |
| Maximum Phase charge<br>(µC) at 500Ω | 16.8 | 17.9 | 15.7 |
| Maximum current density<br>(mA/cm²) at 500Ω | Mode 1: 3.36<br>Mode 2: 5.06<br>Mode 3: 5.12<br>Mode 4: 2.75<br>Mode 5: 2.56<br>Mode 6: This mode cycles the above five modes | 9.92 | Mode 1: 6.48<br>Mode 2: 5.6<br>Mode 3: 7.2<br>Mode 4: 5.6<br>Mode 5: 5.6<br>Mode 6: This mode cycles the above modes |
| Maximum average power<br>density (mW/cm²) at 500Ω | Mode 1: 2.11<br>Mode 2: 0.85~3.75<br>Mode 3: 0.08<br>Mode 4: 2.05<br>Mode 5: 1.64<br>Mode 6: This mode cycles the above five modes | 2.72 | Mode 1: 0.52<br>Mode 2: 0.39<br>Mode 3: 0.65<br>Mode 4: 0.39<br>Mode 5: 0.39<br>Mode 6: This mode cycles the above modes |
| Compliance with Voluntary<br>Standards | 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 CFR<br>898 | 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.