TANYX

K123866 · Medecell Us, Inc. · NUH · Sep 13, 2013 · Neurology

Device Facts

• Record ID: K123866
• Device Name: TANYX
• Applicant: Medecell Us, Inc.
• Product Code: NUH · Neurology
• Decision Date: Sep 13, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Tanyx is a disposable, portable, battery-operated transcutaneous electrical nerve stimulator (TENS) for OTC use. Device adheres directly to skin; emits controlled monophasic, rectangular electrical signals via integrated electrode grid to reduce pain. User operates via power and intensity buttons. No medical supervision required. Output modes include fixed or modulated signals; burst mode available. Device provides temporary pain relief for sore/aching muscles in arms, legs, and lower back. Benefits include ease of use, portability, and non-invasive pain management.

Clinical Evidence

Bench testing only. Biocompatibility testing (ISO 10993-1, 5, 10) passed. Device safety testing (IEC 60601-1, IEC 60601-2-10) passed. Hazard analysis conducted per ISO 14971:2007. Usability study confirmed users could operate the device correctly and safely.

Technological Characteristics

Materials: ABS and Polypropylene. Sensing/Actuation: Microprocessor-controlled TENS. Energy: Battery-powered. Form factor: 153mm x 51mm x 8.2mm, 30g. Output: Monophasic, rectangular waveform, 55 Hz frequency, 6 output modes, 1 channel. Connectivity: Standalone. Sterilization: Not specified.

Indications for Use

Indicated for adults for temporary relief of pain associated with sore/aching muscles in arms, legs, and lower back due to exercise or normal household/work strain. Contraindications not specified.

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

• Model PM3030 (K110068)

Submission Summary (Full Text)

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K23866

#### 510(k) Summary

Date of Submission: November 28, 2012

Submitter: Medecell US, Inc. 4901 Boulder Lane Hoffman Estates, IL 60010-5842 [phone] Phone: Robert Da Rocha, International Director Contact Person:

#### Subject Device:

Tanyx® Proprietary Name: Stimulator, Nerve, Transcutaneous, Over-The-Counter Classification Name: Regulation: 882.5899 Product Code: nuh

SEP 1.3 2013

#### Predicate Devices:

| Name of device | Model PM3030 |
|----------------|-------------------|
| Manufacturer: | Omron Health Care |
| K number: | K110068 |
| Product Code: | NUH |

#### Device Description:

TANYX® is based on TENS medical technology. The product is to reduce or eliminate pain through the emission of controlled and focused electrical signals. It is a disposable device, designed to be sold directly to consumers for the temporary relief of pain. TANYX® adheres to a person's skin and emits either a fixed or modulated electrical signal through a grid of integrated electrodes. It is a product which is characterized as portable, inexpensive, disposable, and (compared to other TENS-based products) easy to handle and operate. No medical supervision is required.

#### Intended Uses:

"To be used in adults only for temporary relief of pain associated with sore and aching muscles in the upper extremities (arms), lower extremities (legs), and lower back due to strain from exercise or normal household and work activities."

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### Summary of Technological Characteristics:

| | Model PM3030 | TANYX® |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Manufacturer: Omron Healthcare, Inc. | Manufacturer: Medecell do Brasil |
| | | K110068 |
| Indications for Use | This device is intended for the relief of pain<br>associated with sore or aching muscles of the<br>lower back, arms, or legs due to strain from<br>exercise or normal household and work<br>activities. | To be used for temporary relief of pain<br>associated with sore and aching muscles in the<br>upper extremities (arms), lower extremities<br>(legs), and lower back due to strain from exercise<br>or normal household and work activities. |
| Patient Population | Adults | Adults |
| Prescriptive or OTC | OTC | OTC |
| Environment Of use | Clinics, hospital and home environments | Clinics, hospital and home environments |
| Number Of Output modes | 3 | 6 |
| Number of output channels | 1 | 1 |
| Waveform | Biphasic | Monophasic |
| Shape | Rectangular | Rectangular |
| Maximum Output Voltage<br>(max) | | |
| 500 ohm | 35.4 V | 47.6 Vpp |
| 2k ohm | 46.7 V | 64.0 Vpp |
| 10k ohm | 50.8 V | 72.8 Vpp |
| Frequency (Hz) | 0-100 Hz | 55 Hz |
| Maximum Output Current<br>(max) | | |
| 500 ohm | 4.4 mA | 95.2 mApp |
| 2k ohm | 1.7 mA | 29.1 mApp |
| 10k ohmn | 0.4 mA | 7.9 mApp |
| Maximum Average Current | 3.5mA | 6.02mA |
| Maximum Current Density | 0.095mA/Cm² | 0.12mA/Cm² |
| Maximum Average Power<br>Density | 89mW/Cm² | 98mW/Cm² |
| Maximum Phase charge (500<br>ohm) | 1.33 µC | 0.19 µC |
| Burst Mode | none | yes |
| Timer range (min) | 15 minutes | No |
| Dimensions | 55 mm x 95 mm x 19mm | 153mm x 51mm x 8.2mm |
| Weight | 60 grams | 30 grams |
| Material | Acrylonitrile Butadiene Styrene (ABS) | Acrylonitrile Butadiene Styrene (ABS) and<br>Polypropylene (PP) |
| Microprocessor control | Yes | yes |
| Automatic Overload trip | Yes | No |
| Automatic no-load trip | Yes | Yes |
| Automatic shut-off | Yes | No |
| User control | Power On/Off button | Power On/Off and Intensity buttons |
| Electrode cable | Yes | No |

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#### Differences between Tanyx and Predicate Device

Tanyx is viewed as substantially equivalent to the predicate device because the stimulation parameters are all in the same range for the intended use. The device includes a wide variation in terms of Current, Voltage Amplitude and Waveform, the basic parameters, without sacrificing biological effects. Maximum Output Current differences between Tanyx and the predicate device are due to different measurement methods. Tanyx was measured using a peak-to-peak value and predicate device uses RMS value, but both devices are in the same range of safety and efficacy. Other measurement differences are not significant from the predicated device. Operation and mechanical design don't show significant differences.

#### Non-Clinical Performance Data:

| Characteristic | Predicate | Subject |
|-------------------|---------------|---------|
| | | |
| Biocompatibility | | |
| ISO 10993-1 | Passed | Passed |
| ISO 10993-5:2009 | Not specified | Passed |
| ISO 10993-10:2010 | Not specified | Passed |
| | | |
| Device Safety | | |
| IEC 60601-1 | Passed | Passed |
| IEC 60601-2-10 | Passed | Passed |
| | | |
| Hazard Analysis | | |
| ISO 14971:2007 | Not Specified | Passed |

#### Risk Analysis Method:

The hazard analysis for the device was conducted according to EN ISO 14971:2007. The device was found to adequately minimize the risks for shock and burn as identified by FDA.

#### Usability Study:

A usability study was conducted and showed that users were able to use the device correctly and safely.

#### Conclusion:

Tanyx® is substantially equivalent to a legally marketed device. Although it has some technological characteristics that differ from that of predicate, TENS current state of art support that stimulation parameters of both devices are in the same range for the intended biological effects and practical use and raises no new questions of safety and effectiveness.

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## Summary of substantial equivalence

.

| | Model PM3030 | TANYX® |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Manufacturer: Omron Healthcare, Inc. | Manufacturer: Medecell do Brasil |
| | K110068 | |
| Indications for Use | This device is intended for the relief of<br>pain associated with sore or aching<br>muscles of the lower back, arms, or<br>legs due to strain from exercise or<br>normal household and work activities. | To be used for temporary relief of pain<br>associated with sore and aching muscles<br>in the upper extremities (arms), lower<br>extremities (legs), and lower back due to<br>strain from exercise or normal household<br>and work activities. |
| Patient Population | Adults | Adults |
| Prescriptive or OTC | OTC | OTC |
| Environment Of use | Clinics, hospital and home<br>environments | Clinics, hospital and home environments |
| Number Of Output modes | 3 | 6 |
| Number of output channels | 1 | 1 |
| Waveform | Biphasic | Monophasic |
| Shape | Rectangular | Rectangular |
| Maximum Output Voltage<br>(max) | | |
| 500 ohm | 35.4 V | 47.6 Vpp |
| 2k ohm | 46.7 V | 64.0 Vpp |
| 10k ohm | 50.8 V | 72.8 Vpp |
| Frequency (Hz) | 0-100 Hz | 55 Hz |
| Maximum Output Current<br>(max) | | |
| 500 ohm | 4.4 mA | 95.2 mApp |
| 2k ohm | 1.7 mA | 29.1 mApp |
| 10k ohmn | 0.4 mA | 7.9 mApp |
| Maximum Average Current | 3.5mA | 6.02mA |
| Maximum Current Density | 0.095mA/Cm² | 0.12mA/Cm² |
| Maximum Average Power<br>Density | 89mW/Cm² | 98mW/Cm² |
| Maximum Phase charge<br>(500 ohm) | 1.33 µC | 0.19 μC |
| Burst Mode | none | yes |
| Timer range (min) | 15 minutes | No |
| Dimensions | 55 mm x 95 mm x 19mm | 153mm x 51mm x 8.2mm |
| Weight | 60 grams | 30 grams |
| Material | Acrylonitrile Butadiene Styrene (ABS) | Acrylonitrile Butadiene Styrene (ABS) and<br>Polypropylene (PP) |
| Microprocessor control | Yes | yes |
| Automatic Overload trip | Yes | No |
| Automatic no-load trip | Yes | Yes |
| Automatic shut-off | Yes | No |
| User control | Power On/Off button | Power On/Off and Intensity buttons |
| Electrode cable | Yes | No |

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Qur product Tanyx was tested by the company "No Risk" from Brazil resulting the report R120331 - Medecell - Stimulator - Tanyx - parameters - 12042710 . The numbers collected from this document demonstrate that Tanyx is in accordance to the limits established to the safety of the differences between Tanyx and the other device, we believe do not raise any new question regarding safety and effectiveness because both are under the established limits.

In reference to the MAXIMUM OUTPUT VOLTAGE, our product have numbers under established limits within industry standards and the differences between the devices do not raise any new question of safety and effectiveness.

Regarding the MAXIMUM OUTPUT CURRENT, Tanyx again have our numbers under the established limits and the differences between the devices do not raise any new question of safety and effectiveness because both products are in accordance to industry standards.

Referent to the MAXIMUM PHASE CHARGE, the number for Tanyx is over the established limit and again, the difference between the devices do not raise any question regarding safety and effectiveness because both are under limits.

Regarding the MAXIMUM CURRENT DENSITY of Tanyx, the product is under the maximum limits and because of this do not raise any new question of safety and effectiveness. The differences between the devices do not raise any new question too, because both are under the maximum limits established.

In reference to MAXIMUM AVERAGE CURRENT, Tanyx is under the established maximum limits. The differences between the products do not raise new questions of safety and effectiveness because, as Tanyx, the other device is under the maximum limits.

Regarding MAXIMLUMN AVERAGE POWER DENSITY, the product is under the maximum limits and because of this do not raise any new question of safety and effectiveness. The differences between the devices do not raise any new question too, because both are under the maximum limits established.

In reference to Frequency (Hz) Tanyx has a 55 Hz (this number may vary ± 3%) and this frequency do not raise any new question of effectiveness and safety because it is tested and the differences between the devices to not raise any question two because they are under the limits of patient safety.

Tanyx is viewed as substantially equivalent to the predicate device because the stimulation parameters are all in the same range for the intended use. The device includes a wide variation in terms of Current, Voltage Amplitude and Waveform, the basic parameters, without sacrificing biological effects. Maximum Output Current differences between Tanyx and the predicate device are due to different methods. Tanyx was measured using a peak-to-peak value and predicate device uses RMS value, but both devices are

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in the same range of safety and efficacy. Other measurement differences are not significant from the predicated device. Operation and mechanical design don´t show significant differences.

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Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare. The image is in black and white.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

#### September 13, 2013

Medecell c/o Rhonda Alexander, M.S., M.P.A. Registrar Corp 144 Research Drive Hampton. VA 23666

Re: K123866

Trade/Device Name: Tanyx® Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: July 23, 2013 Received: July 24, 2013

Dear Ms. Alexander:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Rhonda Alexander

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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (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.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# Joyce M. Whang -S

Victor Krauthamer, Ph.D. for Acting 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): K123866

Device Name: Tanyx®

Indications For Use:

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

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ × (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) ·

Concurrence of Center for Devices and Radiological Health (CDRH)

# Joyce M. Whang -S