QUICK RELAX PRO

K131956 · Healthcare Innovations, LLC · NUH · Apr 24, 2014 · Neurology

Device Facts

• Record ID: K131956
• Device Name: QUICK RELAX PRO
• Applicant: Healthcare Innovations, LLC
• Product Code: NUH · Neurology
• Decision Date: Apr 24, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Quick Relax Pro is a handheld, battery-powered (1.5V AA) transcutaneous electrical nerve stimulator (TENS) for OTC pain relief. It features a single-mode, single-function design with a rotating disk to manually adjust microcurrent intensity. The device delivers pulsed asymmetrical biphasic waveforms directly to the body via an integrated electrode. It is intended for patient self-use to provide temporary relief of minor muscle pain in the shoulder, waist, back, neck, and extremities. The device lacks software, microprocessors, or automated shut-off features. Users operate the device by applying the electrode to the affected area and adjusting the current level manually. The device provides a non-pharmacological option for managing muscle soreness.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-5, ISO 10993-10, and ISO 10993-12. Product safety testing performed per IEC 60601-1. Electromagnetic compatibility testing performed per IEC 60601-1-2. No clinical data provided.

Technological Characteristics

Handheld TENS device; 1.5V AA battery powered; flame-retardant ABS and stainless steel construction; pulsed asymmetrical biphasic waveform; 11 µSec pulse duration; 30 Hz frequency; Type BF line current isolation; no software/microprocessor; manual rotating disk intensity control.

Indications for Use

Indicated for temporary relief of minor muscle pain in shoulder, waist, back, neck, arms, and legs caused by exercise or household work. For over-the-counter 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

• HealthmateForever® (K121757)

Submission Summary (Full Text)

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### K131956

### Section 005 – 510(k) Summary

### APR 2 4 2014

.

### Applicant or Sponsor Information

| Name: | Healthcare Innovations, LLC |
|-----------------------------|-----------------------------|
| Address: | 12889 Coco Plum Lane |
| | Naples, FL 34119-8530 |
| Contact: | Dr. John Ricci |
| Phone: | (239) 593 - 9570 |
| Fax: | (239) 593 - 9570 |
| E-mail: | [e-mail] |
| Establishment Registration: | TBD |
| Date of Submission: | 23 June, 2013 |

#### Submission Correspondent (Preparer's) Information

| Name: | Shepard G. Bentley, RAC<br>President, Bentley Biomedical Consulting, LLC<br>Consultant to Healthcare Innovations, LLC |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------|
| Address: | 28241 Crown Valley Parkway<br>Suite 510(k)<br>Laguna Niguel, CA 92677 |
| Device Information | |
| Device Common Name: | Transcutaneous electrical nerve stimulator for pain relief<br>intended for over the counter use |
| Device Trade Name: | Quick Relax Pro |
| Device Classification Name: | Stimulator, nerve, transcutaneous, over-the -counter |

(

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| Device Class: | Class II | |
|------------------|----------|--------------------|
| Product Code: | NUH | |
| CFR Reference: | 882.5890 | |
| Predicate Device | K121757 | HealthmateForever® |

#### Design and Use of the Device

Hand held, 1.5 volt AA battery powered, single mode, single function device with ten "settings" that are controlled by means of rotating a marked disk that increases the microcurrent when rotated clockwise and decreases the microcurrent when rotated counterclockwise, directly through the device integrated electrode into the indicated region of the body. The purpose of the Quick Relax Pro is to provide a temporary relief of minor muscle pain within the indicated region of the body.

### Technological Characteristics Comparison

| Technical Characteristics | Quick Relax Pro | HealthmateForever® Pro-8AB |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | To be used for temporary<br>relief of pain associated with<br>sore and aching muscles in<br>the shoulder, waist, back,<br>neck, upper extremities (arm),<br>and lower extremities (leg)<br>due to strain from exercise or<br>normal household work<br>activities | To be used for temporary<br>relief of pain associated with<br>sore and aching muscles in<br>the shoulder, waist, back,<br>neck, upper extremities (arm),<br>and lower extremities (leg)<br>due to strain from exercise or<br>normal household work<br>activities |
| Battery Powered | 1.5V DC | 3.7V DC |
| Method of Line Current<br>Isolation | Type BF | Type BF |
| Number of Output Modes | 1 | 8 |
| Waveform | Asymetrical Biphasic | Asymetrical Biphasic |
| Software | No | Yes |
| Functions | Single | Multiple |

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| Parameter | | Subject Device | Predicate Device |
|-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------|
| 510(k) Number | | K131956 | K121757 |
| Device Name and Model | | Quick Relax Pro | HealthmateForever |
| Manufacturer | | Healthcare<br>Innovations, LLC | Healthmate<br>International, LLC |
| Power Source(s) | | Battery, single<br>AA dry cell | Battery, single dry<br>cell |
| -Method of Line Current Isolation | | N/A | N/A |
| -Patient Leakage Current | | N/A | N/A |
| -Normal Condition (μC) | | N/A | N/A |
| -Single Fault Condition (µC) | | N/A | N/A |
| Average DC current through electrodes when device is<br>on but no pulses are being applied (µC) | | N/A (pulses<br>always applied<br>when on) | N/A (pulses always<br>applied when on) |
| Number of Output Modes | | 1 | 2 |
| Number of Output Channels | Synchronous or<br>Alternating?<br>Method of<br>Channel<br>Isolation | N/A | N/A |
| Regulated Current or Regulated<br>Voltage? | | N/A | N/A |
| Software/Firmware/Microprocessor Control? | | No | Yes |
| Automatic Overload Trip? | | No | No |
| Automatic No-Load Trip? | | No | No |
| Automatic Shut Off? | | No | No |
| User Override Control? | | No | Yes |
| Indicator Display: | On/Off Status?<br>Low Battery?<br>Voltage/Current<br>Level? | Yes<br>No<br>Yes | Yes<br>Yes<br>Yes |
| Timer Range (minutes) | | N/A | Yes |
| Compliance with Voluntary Standards? | | Yes | Yes |
| Compliance with 21 CFR 898? | | N/A | Presumed |
| Weight (lbs., oz.) | | 4.5 oz | 3.9 oz |
| Dimensions (in) [W x H x D] | | 8.75" x 2" x<br>1.75" | 3.75" x 2" x .5" |
| Housing Materials and Construction | | Flame ret. ABS,<br>stainless steel | Metal, LCD |
| Parameter | Subject Device | Predicate Device | |
| Mode or Program Name | Output | Pro-8AB | |
| Waveform (e.g., pulsed monophasic, biphasic) | Pulsed biphasic (asymmetrical unbalanced) | Pulsed biphasic (asymmetrical unbalanced) | |
| Shape (e.g., rectified, spike, rectified sinusoidal) | Rectified sinusoidal (with undershoot) | Rectangular with taper | |
| Maximum Output Voltage (volts) (+/-5%) | 58.4v @ 500Ω<br>220v @ 2KΩ<br>995v @ 10KΩ<br>applies measure prior to EnCadis' clarification - revised calculation is approx 300v @ 10KΩ | 70v @ 500Ω<br>90v @ 2KΩ<br>100v @10KΩ | |
| Maximum Output Current (mA) (+/- 5%) | 117 mA @ 500Ω<br>110 mA @ 2KΩ<br>100 mA @ 10KΩ | 140 mA @ 500Ω<br>45 mA @ 2KΩ<br>10 mA @ 10KΩ | |
| Duration of primary (depolarizing) phase (µSec) | N/A | unknown | |
| Pulse Duration (µSec) | 11 µSec | 10 mSec | |
| Frequency (Hz) | 30 Hz (max amplitude) | 100 Hz | |
| For multiphasic waveforms only:<br>Symmetrical phases?<br>Phase Duration | No<br><br>Positive Phase:<br>11 µSec<br>Negative Phase:<br>2 µSec (@ min amplitude, 500Ω load)<br>25 µSec (@ max amplitude, 10KΩ load) | No<br><br>Various, all are longer than Quick Relax Pro | |
| Net Charge (microCoulombs (µC) per pulse) | 0.78 µC * | Various, higher | |
| Maximum Phase Charge (µC) | 0.82 µC * | 15.66 µC | |
| Maximum Current Density (mA/cm2, r.m.s.) | 3.37 mA/cm2 r.m.s. | 7.2 mA/cm2 @500Ω | |
| Parameter --------------- | | Subject Device | Predicate Device |
| Maximum Average Current (average absolute value)<br>mA | | 0.220 mA | Not measured |
| Maximum Average Power Density (W/cm2) | | 803 µW/cm2 | Not measured |
| Burst Mode | (a) Pulses per<br>burst | N/A | Various |
| | (b) Bursts per<br>second | N/A | Various |
| | (c) Burst<br>duration | N/A | Various |
| | (d) Duty Cycle:<br>Line b x Line c | N/A | Various |
| ON Time (Sec) | | N/A | 1,200 default |
| OFF Time (Sec) | | N/A | N/A |
| Additional Features | | N/A | Unknown |

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#### Summary of Technological Characteristics Comparison

The foregoing comparison of the technological characteristics of the subject and predicate devices confirms that the devices are substantially equivalent with respect to intended uses, method of powering, physical descriptions, method of isolation and waveforms.

The differences regarding battery power, material descriptions, number of output modes, presence of software and overall numbers of functions confer an added degree of safety to the subject device.

Therefore, the subject device is at least as safe if not safer than the predicate device, and substantially equivalent with regard to the relevant comparators of the devices.

#### Summary of Non-Clinical Testing

The Quick Relax Pro has undergone biocompatibility testing of its tissue-contacting electrode in compliance with ISO 10993-5, ISO 10993-10 and ISO 10993-12. In addition, the Quick Relax Pro has undergone Product Safety testing in compliance to IEC 60601-1 and Electromagnetic Compatibility testing in compliance to IEC 60601-1-2. The results of each of the foregoing sets of test requirements were satisfactory, and serve to demonstrate the safety and effectiveness of the Quick Relax Pro.

The product safety, electromagnetic compatibility and biocompatibility test results provide assurance that the subject device performs as well or better than the predicate device.

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The introduction of the Quick Relax Pro into interstate commerce does not raise any new issues of safety or effectiveness.

and the comments of the count

100 - 100 - 100 -

:

END OF 510(K) SUMMARY

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Image /page/6/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 a stylized symbol that resembles an abstract caduceus or a representation of human services.

#### Public Health Service

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

April 24, 2014

Healthcare Innovations, LLC c/o Shepard G. Bentley, RAC Bentley Biomedical Consulting, LLC 28241 Crown Valley Parkway, Suite 510(k) Laguna Niguel, CA 92677

Re: K131956

Trade/Device Name: Quick Relax Pro Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: March 4, 2014 Received: March 25, 2014

Dear Mr. Bentley:

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

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#### Page 2 - Mr. Shepard Bentley

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/McdicalDcvices/Safety/ReportalProblem/dcfault.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,

Carlos L. Peña AS

Carlos L. Peña, Ph.D., M.S. 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) K131956

#### Device Name

Quick Relax Pro

#### Indications for Use (Describe)

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

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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FOR FDA USE ONLY

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

.

Carlos Pena -S

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

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