HIVOX BIOTEK INC.

K112392 · Hivox Biotek, Inc. · NUH · Mar 19, 2012 · Neurology

Device Facts

• Record ID: K112392
• Device Name: HIVOX BIOTEK INC.
• Applicant: Hivox Biotek, Inc.
• Product Code: NUH · Neurology
• Decision Date: Mar 19, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The HIVOX Electric Stimulator OTC TENS, Pennypad 904 and Pennypad 909 are indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. The HIVOX Electric Stimulator OTC TENS, Pennypad 907 is indicated for Arm & Leg Pain Relief is intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.

Device Story

HIVOX Electric Stimulator OTC TENS (Pennypad 904, 907, 909) is a transcutaneous electrical nerve stimulator; generates small electrical pulses; delivered via skin electrodes to activate underlying nerves; intended for temporary pain relief. Device is compact (113 x 70 x 9.7 mm); operated by patient in home/non-clinical setting. Output parameters (voltage, current, frequency) are user-adjustable; Pennypad 909 includes a 'Burst Mode'. Device provides symptomatic relief of muscle pain; helps patients manage discomfort from strain without prescription intervention.

Clinical Evidence

No clinical data submitted. Substantial equivalence is supported by bench testing, including electrical safety, electromagnetic compatibility, and waveform performance testing.

Technological Characteristics

Transcutaneous electrical nerve stimulator; symmetrical biphasic rectangular waveform; dimensions 113 x 70 x 9.7 mm. Complies with IEC/EN 60601-1 (safety), IEC/EN 60601-1-2 (EMC), and IEC/EN 60601-2-10 (nerve/muscle stimulator safety).

Indications for Use

Indicated for temporary relief of pain in sore/aching muscles of the lower back (Pennypad 904/909) or upper/lower extremities (Pennypad 907) caused by strain from exercise or daily activities. For 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

• Therapeutic Massage Companion, Endurance Therapeutics (K060846)
• Limited Function OTC TENS, WELL-LIFE Healthcare Limited (K040512)

Submission Summary (Full Text)

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HIVOX BIOTEK INC.

5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan . Phone: [phone] Fax: [phone]

## SUMMARY OF SAFETY AND EFFECTIVENESS for HIVOX Electric Stimulator OTC TENS

HIVO>

MAR 1 9 2012

## 510(k): K112392

| DATE OF | |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMISSION: | July 13, 2011 |
| SUBMITTER: | HIVOX BIOTEK INC. |
| | 5F, No.123, Shinde Road, Sanchong Dist.,<br>New Taipei City, 24158, TAIWAN, R.O.C.<br>TEL: [phone] FAX:[phone] |
| ESTABLISHMENT<br>REGISTRATION NO: | 9611558 |
| OFFICIAL<br>CONTACT: | Dr. JEN, KE-MIN<br>TEL: [phone] FAX:[phone]<br>Email: [e-mail] |
| TRADE NAME: | HIVOX Electric Stimulator OTC TENS<br>Pennypad 904 and Pennypad 909 : OTC TENS - Lower<br>Back pain relieve<br>Pennypad 907: OTC TENS - Arm and Leg pain relief |
| COMMON/USUAL<br>NAME: | Stimulator, Nerve, Transcutaneous,<br>Over-The-Counter |
| CLASSIFICATION<br>NAME: | Transcutaneous Nerve Stimulator |
| REGULATION<br>NUMBER: | NUH, Class II, 882.5890 |
| SECONDARY<br>PRODUCT CODE: | GZJ, Class II, 882.5890 |
| PREDICATED<br>DEVICE: | Therapeutic Massage Companion, Endurance Therapeutics<br>1) K060846, OTC TENS for Lower Back, Arm and Leg<br>Pain Relief, T1040<br>WELL-LIFE Healthcare Limited<br>2) K040512, Limited Function OTC TENS, for Lower<br>Back Pain Relief, WL-2402, WL-2403 |

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Image /page/1/Picture/0 description: The image shows the word "HIVOX" in bold, sans-serif font. To the right of the word is a symbol that looks like a plus sign made of squares. The symbol is also in bold and has a similar line thickness to the letters.

ﻪ ﻣﺮ

## HIVOX BIOTEK INC.

5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: [phone] Fax: [phone]

| Intended Use: | The HIVOX Electric Stimulator OTC TENS, Pennypad 904 and<br>Pennypad 909 are indicated for temporary relief of pain associated<br>with sore and aching muscles in the lower back due to strain from<br>exercise or normal household and work activities.<br>The HIVOX Electric Stimulator OTC TENS, Pennypad 907 is<br>indicated for Arm & Leg Pain Relief is intended for temporary<br>relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description of Device: | The HIVOX Electric Stimulator OTC TENS, Pennypad 904,<br>Pennypad 907, and Pennypad 909 can generate small pulses of<br>electrical current. Delivered these pulses pass through the skin and activated underlying nerves. |
| Performance Tests<br>Submitted: | The relevant standards including:<br>1. IEC/EN 60601-1 : Medical electrical equipment Part 1.<br>General requirements for safety, 1996.<br>2. IEC/EN 60601-1-2 : Medical electrical equipment, Part 2.<br>Electromagnetic compatibility - Requirements and tests, 2007.<br>3. IEC/EN 60601-2-10 : Medical electrical equipment, Part 2-10:<br>Particular requirements for safety of nerve and muscle<br>stimulators, 2001. |
| Non-Clinical Tests<br>Submitted: | The HIVOX Electric Stimulator OTC TENS, Pennypad 904,<br>Pennypad 907, and Pennypad 909 have been tested in accordance<br>with applicable standards for medical device electrical safety,<br>electromagnetic compatibility, and the particular requirements for Accessories also meet safety requirements: 510(k) electrodes are<br>specified the safety requirements.<br>System level testing including waveform testing was performed in combination the HIVOX Electric Stimulator OTC TENS. |
| Clinical Tests<br>Submitted: | None |
| Conclusion: | As the product description and tests as above, the new devices:<br>HIVOX Electric Stimulator OTC TENS, Pennypad 904, Pennypad<br>907, and Pennypad 909 are as safe and effective as, and the<br>function in a manner equivalent to the predicate devices: K060846,<br>OTC TENS for Lower Back, Arm and Leg Pain Relief, T1040; and<br>K040512, Limited Function OTC TENS, for Lower Back Pain<br>Relief, WL-2402, WL-2403.<br>Thus the new device is substantially equivalent to the predicate devices in this aspect. |

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Image /page/2/Picture/0 description: The image shows the word "HIVOX" in a bold, sans-serif font. To the right of the "X" is a small, stylized graphic that resembles a plus sign made up of small squares. The letters are uniformly black, providing a stark contrast against the white background.

#### HIVOX BIOTEK INC.

5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: [phone] - Fax: [phone]

# Comparison for Predicate Device & Subject Device

## ● COMPARISON TABLE 1

We present the relevant information for the predicate device here for demonstrating the characteristics of the predicate device.

| Parameter | HIVOX | Well Life<br>(K)040512. | Endurance<br>Therapeutics<br>(K)060846. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|----------------------------------------------------|----------------------|-------------------------|-----------------------------------------|-----------------------|------------------|------|---------------------------------------------|-------|-------|-------|-------|-------------------------|------------------------------------------|-------|-------|-------|-----------------------|------------------|------------|--------------------|----|--------------|-----|----|---------------------|----|---------------|----|----|-------------------------|----|---------------------|----|----|---------------|----|----|----|----|--------------|-----|--|----|----|---------------|---|--|----|----|---------------------|----|--|
| Mode or Program Name | PP909 | PP904 | 2402/2403 | T1040 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Waveform | Symmetrical Biphasic | | Biphasic | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Shape | Rectangular | | Rectangular | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Maximum Output Voltage<br>(Volts) (±20%) | @500Ω | 40.0Vpp | 57.6Vpp | 38.2V rms | 40.7V | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | @2KΩ | 84.0Vpp | 89.6Vpp | 52.8V rms | 105.1V | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | @10KΩ | 92.0Vpp | 96.0Vpp | 84.8V rms | 154.1V | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Maximum Output<br>Current(±20%) | @500Ω | 80.0mApp | 115.2mApp | 76.2mA rms | 81.4mA | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | @2KΩ | 42.0mApp | 44.8mApp | 52.8mA rms | 47.8mA | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | @10KΩ | 9.2mApp | 9.6mApp | 8.48mA rms | 15.4mA | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Duration of primary (depolarizing)<br>phase (µSec) | NA | | NA | NA | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Pulse Duration (µSec) | 200µSec (fixed) | | 250 µSec | 4.1~500mS | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Frequency (Hz) | 35 | | 2, 5, and 40 | 25Hz | 245Hz | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Net Charge (µC)<br>per pulse | @500Ω | 0.3200 | 0.2304 | 16.0/8.76 | 4.07 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Maximum Charge (µC) | @500Ω | 16.0 | 23.04 | 12.5/9.2 | 16.9 | Maximum Current Density<br>(mA/cm², r.m.s.) | @500Ω | 1.964 | 2.828 | 0.006 | 2.71 | Maximum Average Power<br>Density (W/cm²) | @500Ω | 0.078 | 0.163 | 0.000848/<br>0.002292 | 5.35<br>(mW/cm²) | Burst Mode | a. Pulse per burst | 1 | NA | NA | NA | b. Burst per second | 4 | NA | NA | NA | c. Burst duration (sec) | 2 | NA | NA | NA | d. Duty Cycle | 8 | NA | NA | NA | ON Time(sec) | 120 | | NA | NA | Off Time(sec) | 0 | | NA | NA | Additional Features | NA | |
| Maximum Charge (µC) | @500Ω | 16.0 | 23.04 | 12.5/9.2 | 16.9 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Maximum Current Density<br>(mA/cm², r.m.s.) | @500Ω | 1.964 | 2.828 | 0.006 | 2.71 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Maximum Average Power<br>Density (W/cm²) | @500Ω | 0.078 | 0.163 | 0.000848/<br>0.002292 | 5.35<br>(mW/cm²) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Burst Mode | a. Pulse per burst | 1 | NA | NA | NA | b. Burst per second | 4 | NA | NA | NA | c. Burst duration (sec) | 2 | NA | NA | NA | d. Duty Cycle | 8 | NA | NA | NA | ON Time(sec) | 120 | | NA | NA | Off Time(sec) | 0 | | NA | NA | Additional Features | NA | | NA | NA | | | | | | | | | | | | | | | | |
| Burst Mode | | a. Pulse per burst | 1 | NA | NA | NA | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | b. Burst per second | 4 | NA | NA | NA | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | c. Burst duration (sec) | 2 | NA | NA | NA | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | d. Duty Cycle | 8 | NA | NA | NA | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| ON Time(sec) | 120 | | NA | NA | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Off Time(sec) | 0 | | NA | NA | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Additional Features | NA | | NA | NA | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

Note: The subject device only Pennypad 909 has the "Burst Mode".

Formula

inula
Current Density – ((Max Voltage@500ohm)x1000)/electrode area (40.732cm²)

Power Density – (Amp x V)/ Electrode Area(40.732cm²)

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# HIV

## HIVOX BIOTEK INC.

5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: [phone] Fax: [phone]

### ● COMPARISON TABLE 2

We present the relevant information for the predicate device here for demonstrating the characteristics of the predicate device.

| Parameter | | HIVOX | Endurance<br>Therapeutics<br>(K)060846 |
|-------------------------------------------------------|-------------------------|-------------------------|----------------------------------------|
| Mode or Program Name | | PP907 | T1040 |
| Waveform | | Symmetrical<br>Biphasic | Biphasic |
| Shape | | Rectangular | Rectangular |
| Maximum Output Voltage (Volts) (±20%)<br>Peak to peak | @500Ω | 68.8V | 40.7V rms |
| | @2KΩ | 88.0V | 105.1 V rms |
| | @10KΩ | 95.2V | 154.1V rms |
| Maximum Output Current(±20%)<br>Peak to peak | @500Ω | 137.6mA | 81.4mA rms |
| | @2KΩ | 44.0mA | 47.8mA rms |
| | @10KΩ | 9.52mA | 15.4mArms |
| Duration of primary (depolarizing) phase (µSec) | | NA | NA |
| Pulse Duration (µSec) | | 200µSec (fixed) | 4.1~500mS |
| Frequency (Hz) | | 2 and 40 | 245Hz |
| Net Charge (µC) per pulse | @500Ω | 1.1008 | 4.07 |
| Maximum Charge (µC) | @500Ω | 27.52 | 16.9 |
| Maximum Current Density<br>(mA/cm², r.m.s.) | @500Ω | 3.378 | 2.71 |
| Maximum Average Power Density<br>(W/cm²) | @500Ω | 0.232 | 5.35<br>(mW/cm²) |
| Burst Mode | a. Pulse per burst | NA | NA |
| | b. Burst per second | NA | NA |
| | c. Burst duration (sec) | NA | NA |
| | d. Duty Cycle | NA | NA |
| ON Time(sec) | | 120 | NA |
| Off Time(sec) | | 0 | NA |
| Additional Features | | NA | NA |

#### Formula:

r critical
Current Density – ((Max Voltage(@500ohm)x1000)/electrode area (40.732cm²) Power Density - (Amp x V)/ Electrode Area(40.732cm2)

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5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: [phone] Fax: [phone]

#### DISCUSSION:

・・

The HIVOX Electric Stimulator OTC TENS, Pennypad 904, Pennypad 907, and Pennypad 909 have the same visional appearance, software, and dimensions ( 113 * 70 * 9.7 mm ) the main difference is:

- Pennypad 904 and Pennypad 909 : OTC TENS Lower Back pain relieve ●
- Pennypad 907: OTC TENS Arm and Leg pain relief ●
- Only Pennypad 909 has the "Burst Mode".

As the product description and tests as above, the new devices: HIVOX Electric Stimulator OTC TENS, Pennypad 904, Pennypad 907, and Pennypad 909 are as safe and effective as, and the function in a manner equivalent to the predicate devices: K060846, OTC TENS for Lower Back, Arm and Leg Pain Relief, T1040; and K040512, Limited Function OTC TENS, for Lower Back Pain Relief, WL-2402, WL-2403.. Thus the new devices are substantially equivalent to the predicate devices in this aspect.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem.

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

HIVOX BIOTEK, Inc. c/o Dr. Ke-Min Jen Official Correspondent 5F., No. 123, Shinde Road Sanchong District New Taipei City China, Taiwan 24158

MAR 1 9 2012

Re: K112392

Trade/Device Name: HIVOX Electric Stimulator OTC TENS Models: Pennypad 904, 909 -- Lower back pain relief Pennypad 907 - Arm and Leg pain relief Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH Dated: February 24, 2012 Received: March 8, 2012

Dear Dr. Jen:

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 fray of our of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Dr. Ke-Min Jen

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 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/CDRHQffices/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 vours.

Kesia Alexander

\$\fn\$

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number:

KII2392

Device Name:

HIVOX Electric Stimulator OTC TENS Pennypad 904, 909 : OTC TENS – Lower back pain relieve Pennypad 907: OTC TENS – Arm and Leg pain relief

#### Indications for Use :

The Pennypad 904 and Pennypad 909 are indicated for temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.

The Pennypad 907 is indicated for Arm & Leg Pain Relief is intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) 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 _ V (21 CFR 807 Subpart C)

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

Concurrence of CDRH Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
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Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
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