HEALTHMATEFOREVER

K121757 · Healthmate International, LLC · NUH · Nov 20, 2012 · Neurology

Device Facts

• Record ID: K121757
• Device Name: HEALTHMATEFOREVER
• Applicant: Healthmate International, LLC
• Product Code: NUH · Neurology
• Decision Date: Nov 20, 2012
• 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, neck, 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

Portable, battery-powered (3.7V DC) device providing TENS and PMS therapy. Device delivers programmed electrical pulses via adhesive electrode pads to body areas, causing minimal muscle contractions. Features 6 modes of operation; single or dual-channel output. Used by patients in home or non-clinical settings without medical supervision. User selects mode and placement based on instruction manual. Output affects muscle performance and provides temporary pain relief. Benefits include non-pharmacological pain management and muscle conditioning.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5, and ISO 10993-10. Software verification performed per FDA guidance. Safety supported by historical data of 100,000+ units sold in Europe and Asia since 2007 with no reported adverse events.

Technological Characteristics

Battery-powered (3.7V DC) electrical stimulator. Dual/single channel output. Materials include electrode adhesive pads. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-2-10 (nerve/muscle stimulators), ISO 10993-5/10 (biocompatibility). Software-controlled pulse generation.

Indications for Use

Indicated for individuals experiencing temporary pain in muscles of the shoulder, waist, back, neck, arms, or legs due to exercise or household strain (TENS), and for stimulation of healthy muscles to improve or facilitate muscle performance (PMS).

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

• JQ-5C (K102598)

Submission Summary (Full Text)

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K121757

HealthmateForever ® Healthmate International, LLC

> 709 E 97th St. , Kansas City MO 64131 Tel: [phone]

#### Section 5 510(k) Summary

# 1. Submitter's Identifications

Submission type: abbreviated Basis for submission: New device Submitter's Name: Healthmate International, LLC Address: 709 East 97th Street, Kansas City MO 64131 Contact Person: Mei Dodson Contact Email: [e-mail] Tel: [phone] Prepared date: 9/28/2012

# 2. Correspondent's Identifications

Correspondent's Name: Healthmate International, LLC Address: 709 East 97th Street, Kansas City MO 64131 Contact Person: Mei Dodson Contact Email: [e-mail] Tel: [phone]

## 3. Name of the Device

Device Classification Name: Stimulator, Muscle, Powered, Over-the-Counter Device Name: TENS and Powered Muscle Stimulator Models: Pro-8AB, Pro-8IS, Plus-6AB, Plus-6IS, TCM-6L, iTone Trade Name: HealthmateForever ® Regulation Number: 21 CFR 882.5890 OTC & 21 CFR 882.5850. Product Code: NUH & NGX Device Classification: Class II

## 4. The Predicate Device

| K102598 | JQ-5C | TENS | 21 CFR 882.5890 OTC |
|---------|-------|------|---------------------|
| K102598 | JQ-5C | PMS | 21 CFR 882.5850 OTC |

## 5. Device Description

Pro-8AB is portable; battery powered (3.7V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (PMS) qualities in one device.

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Double or single channel that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 6 modes of operations. The electrodes that we choose to use with the devices, and that any technical characteristics that are

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#### HealthmateForever ® Healthmate International, LLC 709 E 97th St., Kansas City MO 64131 Tel: [phone]

dependent on the chosen electrodes are consistent with the electrodes that we choose to use with the devices.

# 6. Intended Use of Device

## TENS:

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.

# PMS:

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

The intended use is the same as the predicate device.

# 7. Summary of Substantial Equivalence

Table: The difference between a series of new devices and Predicate JQ-5C.

| Quantity | Pro-8AB, Pro-8IS, Plus-6AB,<br>Plus-6IS, TCM-6L, iTone | JQ-5C |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|
| Max Voltage over 10kΩ, V | 100 | 84 |
| Max. Current over 10kΩ, mA | 10 | 8.4 |
| Max. Voltage over 2.2KΩ, V | 90 | 79.2 |
| Max. Current over 2.2KΩ, mA | 45 | 39.6 |
| Max. Voltage over 500,V | 70 | 62.4 |
| Max. Current over 500, mA | 140 | 124.8 |
| Pulse Width, useconds | 90 | 100 |
| Pulse period, msec | 10-836 | 16.3-781 |
| Max. Pulse Frequency, Hz | 100 | 61.3 |
| Max Charge per Phase over 500Ω, µC | 15.66 | 17.92 |
| Max Current Density over 500Ω, mA/cm2 | M1: 6.48@500Ω<br>M2: 5.6@500Ω<br>M3: 7.2@500Ω<br>M4: 5.6@500Ω<br>M5: 5.6@500Ω<br>M6: 7.2@500Ω<br>5.6@500Ω<br>6.48@500Ω<br>M7: 5.76@500Ω<br>M8: 6.48@500Ω<br>5.6@500Ω<br>7.2@500Ω | 9.92 |
| | 5.6@500Ω | |
| | 5.6@500Ω | |
| Max. Average Power Density over 500Ω,<br>mW cm2 | M1: 0.52@500Ω<br>M2: 0.39@500Ω<br>M3: 0.65@500Ω<br>M4: 0.39@500Ω<br>M5: 0.39@500Ω<br>M6: 0.65@500Ω<br>0.39@500Ω<br>0.52@500Ω<br>M7: 0.41@500Ω<br>M8: 0.52@500Ω<br>0.39@500Ω<br>0.65@500Ω<br>0.39@500Ω<br>0.39@500Ω | 2.72 |
| Max Current Density over 500Ω, mA/cm2 | M1: 3.6@500Ω<br>M2: 3.1@500Ω<br>M3: 4@500Ω<br>M4: 3.1@500Ω<br>M5: 3.1@500Ω<br>M6: 4@500Ω<br>3.1@500Ω<br>3.6@500Ω<br>M7: 3.2@500Ω<br>M8: 3.6@500Ω<br>3.1@500Ω<br>4@500Ω<br>3.1@500Ω<br>3.1@500Ω | 9.92 |
| Max. Average Power Density over 500Ω,mW<br>cm2 | M1: 0.29@500Ω<br>M2: 0.22@500Ω<br>M3: 0.36@500Ω<br>M4: 0.22@500Ω<br>M5: 0.22@500Ω<br>M6: 0.36@500Ω<br>0.22@500Ω<br>0.29@500Ω<br>M7: 0.23@500Ω<br>M8: 0.29@500Ω<br>0.22@500Ω<br>0.36@500Ω<br>0.22@500Ω<br>0.22@500Ω | 2.72 |

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#### HealthmateForever ® Healthmate International, LLC 709 E 97th St., Kansas City MO 64131 Tel: [phone]

## 8. Substantial Equivalence

The electrical stimulation provided by a series of model Pro-8AB, Pro-81S, Plus-6AB, Plus-6IS, TCM-6L and iTcne are substantially equivalent to that commonly employed by muscle stimulators and TENS devices that have been cleared for marketing without prescription labeling: i.e., for OTC sale. The pulses in the wave form combinations are restricted in amplitude and duration to values consistent with the other device quoted above.

Technological characteristics, features, specifications, materials and intended uses of the series of model Pro-8AB. Pro-8IS, Plus-6AB, Plus-6IS, TCM-6L and iTone are substantially equivalent to the quoted predicate device.

The differences that exist between the devices are insignificant in the terms of safety or effectiveness.

Model Pro-8AB, Pro-8IS, Plus-6IS, TCM-6L and iTone modes that offer substantially equivalent technical specifications, features and effective results as the predicate tisted.

## 9. Non-Clinical Tests Performed

Compliance to applicable voluntary standards include: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ISO 10993-5 and ISO 10993-10.

In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software in Medical Devices.

## 10. Conclusion:

The electrical stimulation provided by a series of model Pro-8AB. Pro-8IS, Plus-615, TCM-6L and iTone are similar to the commonly employed muscle stimulators and TENS devices that have been cleared for marketing without prescription labeling.

These models have the same intended use and the similar technological characteristics as this OTC predicate. Moreover, verification and validation tests contained in this submission demonstrate that the differences in these models still maintain the same safety and effectiveness as that of the cleared

device.

In other words, those engineering differences do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

Concerns of safe and proper use of electrodes and electrode pad placement have been fully addressed by making the use conscious of the proper placement of the electrodes and proper operations of the device through detail in the User's Instruction Manual.

We believe that there are no new safety or effectiveness issues concerning this device to be introduced.

The safety of the device, to be used for the proposed indications without medical prescriptions or supervision, is established by the fact that no adverse events have been reported since 2007 with over 100,000 units sold without a prescription in Europe and Asia.

Over 100,000 units sold with no adverse effects reported, proves its specific technical, safety measures and features are safe and effective when used without medical supervision.

The effectiveness of the device for the proposed indications is supported by a number of customer re

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views, which demonstrate that electrical stimulation does improve muscle performance as well as temporary pain reduction.

Technological characteristics, features, specifications, materials and intended uses of the series of model Pro-8AB, Pro-8IS, Plus-6AB, Plus-6IS, TCM-6L and iTone are substantially equivalent to the quoted predicate device.

The differences that exist between the devices are insignificant in the terms of safety or effectiveness.

Model Pro-8AB, Pro-8IS, Plus-6AB, Plus-6IS, TCM-6L and iTone offer substantially equivalent technical specifications, features and effective results as the predicate listed.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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November 21, 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Healthmate International, LLC % Ms. Mei Dodson 709 E. 97th Street Kansas City, Missouri 64131

Re: K121757

Trade/Device Name: HealthmateForever Pro-8AB; Plus-6AB; Plus-6AB; Plus-6IS; TCM-6L; and iTone Models Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH, NGX Dated: November 9, 2012 Received: November 14, 2012

Dear Ms. Dodson:

This letter corrects our substantially equivalent letter of November 20, 2012.

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 (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.

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

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Page 2 - Ms. Mei Dodson

CFR Part 807): labeling (21 CFR Part 801); medical device reporting (reporting of medical 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Kesia Y. Alexander

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Healthmate International, LLC HealthmateForever ®

Td: 816 248 1318 709 E 97ª St. , Kansan City MO 64131

#### Section 4 Indications for Use

510 (k) Number (if known): K121757 Device Name: TENS & PMS Models: Pro-8AB, Pro-81S, Plus-6AB, Plus-6IS, TCM-6L & Tone Indications for use:

## TENS (Transcutaneous Electrical Nerve Stimulation)

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.

### PMS (Powered Muscle Stimulator)

It is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.

Prescription Use (Part 2) CFR 801 Subpart D) ' AND/OR .

Over-the-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off) Division of Neurological and Pl Medicine Devices S10(k) Number