LogoFDA 510(k) Search
K Number
K112392
Device Name
HIVOX BIOTEK INC.
Manufacturer
HIVOX BIOTEK, INC.
Date Cleared
2012-03-19

(214 days)

Product Code
NUH
Regulation Number
882.5890
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
The HIVOX Electric Stimulator OTC TENS, Pennypad 904, Pennypad 907, and Pennypad 909 can generate small pulses of electrical current. Delivered these pulses pass through the skin and activated underlying nerves.
More Information

K060846, K040512

Not Found

No
The summary describes a TENS device that generates electrical pulses and does not mention any AI/ML components or capabilities.

Yes
The device is indicated for "temporary relief of pain associated with sore and aching muscles," which is a therapeutic purpose. It is also an OTC (Over-The-Counter) device, strengthening its classification as a therapeutic device.

No

Explanation: The "Intended Use / Indications for Use" section clearly states that the devices are for "temporary relief of pain" and describes their mechanism as generating electrical pulses to activate nerves. There is no mention of diagnosing any condition or providing information about a patient's health status. It is a pain relief device, not a diagnostic one.

No

The device description explicitly states that the device "can generate small pulses of electrical current" and mentions testing in accordance with standards for "medical device electrical safety" and "particular requirements for safety of nerve and muscle stimulators," indicating it is a hardware device that delivers electrical stimulation.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
  • Device Description and Intended Use: The description clearly states that this device is an "Electric Stimulator OTC TENS" that generates electrical pulses delivered through the skin to activate underlying nerves for pain relief. It does not involve the analysis of any biological specimens.

The device described is a Transcutaneous Electrical Nerve Stimulation (TENS) device, which is a type of medical device used for pain management by applying electrical stimulation to the body's surface. This is a completely different category of medical device than an IVD.

N/A

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

NUH, GZJ

Device Description

The HIVOX Electric Stimulator OTC TENS, Pennypad 904, Pennypad 907, and Pennypad 909 can generate small pulses of electrical current. Delivered these pulses pass through the skin and activated underlying nerves.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lower back, upper and lower extremities (arm and/or leg)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Tests Submitted:
The relevant standards including:

  1. IEC/EN 60601-1 : Medical electrical equipment Part 1. General requirements for safety, 1996.
  2. IEC/EN 60601-1-2 : Medical electrical equipment, Part 2. Electromagnetic compatibility - Requirements and tests, 2007.
  3. IEC/EN 60601-2-10 : Medical electrical equipment, Part 2-10: Particular requirements for safety of nerve and muscle stimulators, 2001.

Non-Clinical Tests Submitted:
The HIVOX Electric Stimulator OTC TENS, Pennypad 904, Pennypad 907, and Pennypad 909 have been tested in accordance with applicable standards for medical device electrical safety, electromagnetic compatibility, and the particular requirements for Accessories also meet safety requirements: 510(k) electrodes are specified the safety requirements. System level testing including waveform testing was performed in combination the HIVOX Electric Stimulator OTC TENS.

Clinical Tests Submitted:
None

Conclusion:
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 device is substantially equivalent to the predicate devices in this aspect.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K060846, K040512

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
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.(b)
Classification. Class II (performance standards).

0

HIVOX BIOTEK INC.

5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan . Phone: +886 2 8511 2668 Fax: +886 2 8511 2669

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.,
New Taipei City, 24158, TAIWAN, R.O.C.
TEL: 886-2-85112668 FAX:886-2-85112669
ESTABLISHMENT
REGISTRATION NO:9611558
OFFICIAL
CONTACT:Dr. JEN, KE-MIN
TEL: 886-2-85112668 FAX:886-3-5209783
Email: ceirs.jen@msa.hinet.net
TRADE NAME:HIVOX Electric Stimulator OTC TENS
Pennypad 904 and Pennypad 909 : OTC TENS - Lower
Back pain relieve
Pennypad 907: OTC TENS - Arm and Leg pain relief
COMMON/USUAL
NAME:Stimulator, Nerve, Transcutaneous,
Over-The-Counter
CLASSIFICATION
NAME:Transcutaneous Nerve Stimulator
REGULATION
NUMBER:NUH, Class II, 882.5890
SECONDARY
PRODUCT CODE:GZJ, Class II, 882.5890
PREDICATED
DEVICE:Therapeutic Massage Companion, Endurance Therapeutics
  1. K060846, OTC TENS for Lower Back, Arm and Leg
    Pain Relief, T1040
    WELL-LIFE Healthcare Limited
  2. K040512, Limited Function OTC TENS, for Lower
    Back Pain Relief, WL-2402, WL-2403 |

1

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: +886 2 8511 2668 Fax: +886 2 8511 2669

| 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. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description of Device: | The HIVOX Electric Stimulator OTC TENS, Pennypad 904,
Pennypad 907, and Pennypad 909 can generate small pulses of
electrical current. Delivered these pulses pass through the skin and activated underlying nerves. |
| Performance Tests
Submitted: | The relevant standards including:

  1. IEC/EN 60601-1 : Medical electrical equipment Part 1.
    General requirements for safety, 1996.
  2. IEC/EN 60601-1-2 : Medical electrical equipment, Part 2.
    Electromagnetic compatibility - Requirements and tests, 2007.
  3. IEC/EN 60601-2-10 : Medical electrical equipment, Part 2-10:
    Particular requirements for safety of nerve and muscle
    stimulators, 2001. |
    | Non-Clinical Tests
    Submitted: | The HIVOX Electric Stimulator OTC TENS, Pennypad 904,
    Pennypad 907, and Pennypad 909 have been tested in accordance
    with applicable standards for medical device electrical safety,
    electromagnetic compatibility, and the particular requirements for Accessories also meet safety requirements: 510(k) electrodes are
    specified the safety requirements.
    System level testing including waveform testing was performed in combination the HIVOX Electric Stimulator OTC TENS. |
    | Clinical Tests
    Submitted: | None |
    | Conclusion: | 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 device is substantially equivalent to the predicate devices in this aspect. |

2

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: +886 2 8511 2668 - Fax: +886 2 8511 2669

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
(K)040512. | Endurance
Therapeutics
(K)060846. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|----------------------------------------------------|----------------------|-------------------------|-----------------------------------------|-----------------------|------------------|------|---------------------------------------------|-------|-------|-------|-------|-------------------------|------------------------------------------|-------|-------|-------|-----------------------|------------------|------------|--------------------|----|--------------|-----|----|---------------------|----|---------------|----|----|-------------------------|----|---------------------|----|----|---------------|----|----|----|----|--------------|-----|--|----|----|---------------|---|--|----|----|---------------------|----|--|
| Mode or Program Name | PP909 | PP904 | 2402/2403 | T1040 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Waveform | Symmetrical Biphasic | | Biphasic | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Shape | Rectangular | | Rectangular | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Maximum Output Voltage
(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
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)
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)
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
(mA/cm², r.m.s.) | @500Ω | 1.964 | 2.828 | 0.006 | 2.71 | Maximum Average Power
Density (W/cm²) | @500Ω | 0.078 | 0.163 | 0.000848/
0.002292 | 5.35
(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
(mA/cm², r.m.s.) | @500Ω | 1.964 | 2.828 | 0.006 | 2.71 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Maximum Average Power
Density (W/cm²) | @500Ω | 0.078 | 0.163 | 0.000848/
0.002292 | 5.35
(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)

3

Image /page/3/Picture/0 description: The image shows a blurry, black and white close-up of what appears to be a small object or mark. The object is positioned off-center, with some indistinct features. Due to the lack of clarity, it is difficult to determine the exact nature or context of the image.

HIV

HIVOX BIOTEK INC.

5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669

● COMPARISON TABLE 2

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

| Parameter | | HIVOX | Endurance
Therapeutics
(K)060846 |
|-------------------------------------------------------|-------------------------|-------------------------|----------------------------------------|
| Mode or Program Name | | PP907 | T1040 |
| Waveform | | Symmetrical
Biphasic | Biphasic |
| Shape | | Rectangular | Rectangular |
| Maximum Output Voltage (Volts) (±20%)
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%)
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
(mA/cm², r.m.s.) | @500Ω | 3.378 | 2.71 |
| Maximum Average Power Density
(W/cm²) | @500Ω | 0.232 | 5.35
(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)

4

5F., No. 123, Shingde Road, Sanchong District, New Taipei City, Taiwan Phone: +886 2 8511 2668 Fax: +886 2 8511 2669

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.

5

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.

6

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 (800) 638-2041 or (301) 796-7100 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

7

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)

Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices
Page 1 of 1K112392