HIVOX SELF ADHESIVE ELECTRODE GEL PADS

• K Number: K131720
• Device Name: HIVOX SELF ADHESIVE ELECTRODE GEL PADS
• Manufacturer: HIVOX BIOTEK, INC.
• Date Cleared: 2014-07-25 ( 408 days)
• Product Code: GXY GYB
• Regulation Number: 882.1320

Intended Use

HIVOX self-adhesive electrode gel pads are intended for use as disposable, conductive adhesive interface between the patient's skin and the electrical stimulator. The device is a gel pad for use with an electrode itself.

Device Description

HIVOX self-adhesive electrode gel pads are series of cutaneous electrodes with various shapes and sizes, which use the same materials from the predicate suppliers, i.e. K070612 (Top-Rank Health Care Equipment Co., Ltd. ) and K000947 (Axelgaard Mfg. Co., Ltd.). HIVOX self-adhesive electrode gel pads are non-sterile, self-adhesive, for single patient use only, and to be disposable.

Predicate Devices

K070612, K132588, K000947

Reference Devices

K070612, K000947

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly define the product as simple electrode gel pads, with no mention of AI or ML capabilities.

Therapeutic

No
The device is described as an "adhesive interface" and "gel pad for use with an electrode itself," indicating it is an accessory for an electrical stimulator, rather than a therapeutic device that directly provides therapy.

Diagnostic

No

The device is described as an electrode gel pad for use with an electrical stimulator, serving as a conductive interface. It does not perform any diagnostic function; rather, it is a consumable component used in electrical stimulation.

SaMD (Software as a Medical Device)

No

The device is described as a physical gel pad and electrode, not a software application. The description focuses on materials, shapes, and sizes of a physical product.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is as a "conductive adhesive interface between the patient's skin and the electrical stimulator." This describes a device used externally on the body for electrical stimulation, not for testing samples taken from the body (like blood, urine, or tissue) to diagnose a condition.
• Device Description: The description focuses on the physical characteristics of the gel pads and their use with an electrode for electrical stimulation. There is no mention of analyzing biological samples.
• Performance Studies: The performance studies mentioned are "Biocompatibility Tests" (cytotoxicity, irritation, and sensitization), which are relevant for devices that come into contact with the skin, but not typical for IVD devices which focus on analytical performance.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely as a conductive interface for electrical stimulation applied to the skin.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

HIVOX self-adhesive electrode gel pads are intended for use as disposable, conductive adhesive interface between the patient's skin and the electrical stimulator. The device is a gel pad for use with an electrode and not an electrode itself.

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

GXY, GYB

Device Description

HIVOX self-adhesive electrode gel pads are series of cutaneous electrodes with various shapes and sizes, which use the same materials from the predicate suppliers, i.e. K070612 (Top-Rank Health Care Equipment Co., Ltd. ) and K000947 (Axelgaard Mfg. Co., Ltd.). HIVOX self-adhesive electrode gel pads are non-sterile, self-adhesive, for single patient use only, and to be disposable.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's skin

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: Biocompatibility Tests: · ISO 10993-5:2009, Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity. · ISO 10993-10:2010, Biological evaluation of medical devices -Part 10: Tests for in irritation and skin sensitization. NONE Clinical Tests: Not Found

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.

K070612, K132588, K000947

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

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).

Summary

0

HIVOX

НІУОХ ВІОТЕК INC.

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

		JUL 2 5 2014
	510(K) SUMMARY
(Per 21 CFR 807.92.)	K131720
Submission Date:	July 22, 2014
Submitter:	HIVOX BIOTEK INC.
5F, No.123, Shingde Road, Sanchong Dist.,
New Taipei City, 24158, TAIWAN, R.O.C.
Tel: [phone]
Fax:[phone]
Establishment
Registration No .:	9611558
Official Contact:	Dr. Jen, Ke-Min
Tel: [phone]
Fax:[phone]
Email: [e-mail]
Common /
Usual Name:	Electrode, Cutaneous
Trade Name:	HIVOX self-adhesive electrode gel pads.
510(k) Number:	K131720
Classification
Code:	GXY, Class II, 882.1320
Intended Use:	HIVOX self-adhesive electrode gel pads are intended for use as
disposable, conductive adhesive interface between the patient's
skin and the electrical stimulator. The device is a gel pad for use
with an electrode and not an electrode itself.
Predicated
Devices:	1) K070612, Top-Rank Adhesive Electrodes
Top-Rank Health Care Equipment Co., Ltd.

2. K132588, Top-Rank Adhesive Electrodes
   Top-Rank Health Care Equipment Co., Ltd.
3. K000947, Ultrastim Electrode
   Axelgaard Mfg. Co., Ltd. | |
   | Device Description: | HIVOX self-adhesive electrode gel pads are series of cutaneous
   electrodes with various shapes and sizes, which use the same
   materials from the predicate suppliers, i.e. K070612 (Top-Rank
   Health Care Equipment Co., Ltd. ) and K000947 (Axelgaard Mfg.
   Co., Ltd.). HIVOX self-adhesive electrode gel pads are non-sterile,
   self-adhesive, for single patient use only, and to be disposable. | |

:

1

HIVO

HIVOX BIOTEK INC.

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

Specifications:

HIVOX self-adhesive electrode gel pads have the following possible dimensions and shapes.

Image /page/1/Figure/5 description: The image is an exploded view diagram of a device, possibly a PennyPad Anatomical device body assembly, showing its components and their arrangement. The diagram includes numbered parts such as a Silicon Cover (1), ABS Top Cover (2), Moder Board (3), PET Button Cover (4), Right, Left touch Spring (5), ABS Bottom Cover (6), CR2025 Battery (7), and Battery Cover (8). The diagram also includes a table with the item numbers and corresponding part names.

Scientific Concept: When we put the battery into the stimulator device, and the device will enable to transmit the electric pulse to the device's electrode area. The self-adhesive electrode gel pads should be placed onto the bottom of PET cover to enable to stick on the user's skin and conduct the electric pulse fully around the self-adhesive electrode gel pads. Function and . HIVOX self-adhesive electrode gel pads are non-sterile, Characteristics: self-adhesive, for single patient use only, and to be disposable. · The subject device is designed for Hivox device use only. · HIVOX self-adhesive electrode gel pads are series of cutaneous electrodes with various shapes and sizes, which use the same material as K070612 (Top-Rank Health Care Equipment Co., Ltd. ) and K000947 (Axelgaard Mfg. Co., Ltd.). Performance Tests: Biocompatibility Tests: · ISO 10993-5:2009, Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity. · ISO 10993-10:2010, Biological evaluation of medical devices -Part 10: Tests for in irritation and skin sensitization. NONE Clinical Tests:

2

HIVOX電子

HIVOX BIOTEK INC.

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

Comparison table
Items	Predicate device	Predicate device	Predicate device	Subject Device
Trade Name	Top-Rank Adhesive
Electrode	Top-Rank Adhesive
Electrode	ULTRASTIM
ELECTRODE,
MODEL US4040	HIVOX
self-adhesive
electrode gel pads.
Manufacturer	Top Rank	Top Rank	Axelgaard	Top Rank,
Axelgaard
510(k) Number	K070612	K132588	K000947	K131720
Intended Use	Top-Rank Adhesive
Electrodes are
intended for use as
the disposable,
conductive adhesive
interface between
the patient's skin
and the Electrical
Stimulator.
Top-Rank Adhesive
Electrodes are
intended to be used
with marketed,
Electrical
Stimulators i.e.
TENS
(Transcutaneous
Electrical Nerve
Stimulation) and
EMS (Electrical
Muscular
Stimulation).
These electrodes
will include the
precaution
statement: Federal
Law restricts
the device to sale
by or on the order
of a licensed
practitioner or
therapist.	Adhesive electrodes
are intended for use
as the disposable,
conductive adhesive
interface between
the patient's skin
and the Electrical
Stimulator.
Top-Rank Adhesive
Electrodes are
intended to be used
with marketed,
Electrical
Stimulators i.e.
TENS
(Transcutaneous
Electrical Nerve
Stimulation) and
EMS (Electrical
Muscular
Stimulation).	UltraStim
Electrodes are
intended for use
with a
garment/wrap
designed with a
snap connection for
distributing
electrical impulses
from transcutaneous
neurostimulation
devices to
UltraStim
electrodes placed on
the skin.
Transcutaneous
neurostimulation
electrodes are
passive devices
serving as an
interface between a
patient's skin and a
neurostimulation
device.	HIVOX Self
Adhesive
Electrodes are
intended for use as
disposable,
conductive adhesive
interface between
the patient's skin
and the electrical
stimulator. The
device is a gel pad
for use with an
electrode and not an
electrode itself.
Prescription
Use	Prescription use	OTC	Prescription use	Prescription use &
OTC
Classification
Name	Cutaneous
Electrode	Cutaneous
Electrode	Cutaneous
Electrode	Cutaneous
Electrode

3

HIVO

HIVOX BIOTEK INC.

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

Product Code	GXY 882.1320	GXY 882.1320	GXY 882.1320	GXY 882.1320
Single-Patient
Use	Yes	Yes	Yes	Yes
Multiple
Applications	Yes	Yes	Yes	Yes
Sterility Status	Non-sterile	Non-sterile	Non-sterile	Non-sterile
Biocompatibility
Test	Meets Triparties
Biocompatibility
Guidance for
Medical Devices
&
ISO 10993-5.
ISO 10993-10	Meets Triparties
Biocompatibility
Guidance for
Medical Devices &
ISO 10993-5,
ISO 10993-10	Meets Triparties
Biocompatibility
Guidance for
Medical Devices &
ISO 10993-5,
ISO 10993-10	Meets Triparties
Biocompatibility
Guidance for
Medical Devices &
ISO 10993-5,
ISO 10993-10
Conductive
Surface Shapes	Various shapes
(rectangular,
circle, oval)	Various shapes
(rectangular, circle,
oval)	Various shapes
(rectangular, circle,
oval)	Various shapes
(rectangular, circle,
oval)

Predicated Technological Characteristics Comparison:

The subject device, HIVOX self-adhesive electrode gel pads, uses the same materials from the suppliers, predicate devices' manufacturers. And the suppliers, Top Rank and Axelgaard will provide all components materials of the HIVOX self-adhesive electrode gel pads.

The differences between the subject device and K000947 are prescription use and OTC use. The subject device has OTC use but K000947 hasn't OTC use. But we have added a predicate device K132588 with OTC use, the OTC use of the safety and effectiveness of our device are ensured. The subject device and predicate device (K000947) have the minor different intended use and use the same gel ingredients and the conductive films; thus the effects of impedance levels for the intended situations are the same for both of the devices. We notice there are different wording of the intended uses between the subject device and the predicate device K000947. But the key sentences for K000947 : serving as an interface between a patient's skin and a neurostimulation device, and the key sentences for the subject device : interface between the patient's skin and the electrical stimulator are similar. Thus they have similar intended use. Both of them have the same safety and effectiveness.

4

Image /page/4/Picture/0 description: The image shows the word "HIVOX" in a bold, sans-serif font. To the right of the word is a symbol that looks like four squares connected by curved lines. The symbol is black and white, and it is slightly smaller than the word "HIVOX". The overall image is simple and clean, with a focus on the text and symbol.

HIVOX BIOTEK INC.

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

And all of four devices had passed the Tripartite Biocompatibility Guidance for Medical Devices and the ISO 10993 relevant requirements for skin contact. Thus the subject device and predicate devices have the same safety and effectiveness.

The subject device and the predicate devices have the same physical and technological characteristics, which are intended to be used with marketed Electrical Stimulators, including: TENS(Transcutaneous Electrical Nerve Stimulator), EMS (Electrical Muscular Stimulator), and IF (Interferential Stimulator). And all of the devices are for gel pads use with an electrode and not an electrode itself.

Conclusion:

The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed devices identified in the submission. Thus the subject device is substantially equivalent to the predicate devices.

5

Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the symbol. The text is in all caps and is in a circular format.

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

July 25, 2014

HIVOX BIOTEK, Inc. Dr. Jen. Ke-Min 5 F No. 123 Shinde Road Sanchong District New Taipei City 24158 TAIWAN, ROC

Re: K131720

Trade/Device Name: HIVOX Self-Adhesive Electrode Gel Pads Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrodes Regulatory Class: Class II Product Code: GXY, GYB Dated: June 18, 2014 Received: June 25, 2014

Dear Dr. Jen, Ke-Min,

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 or any reathards and the Act's requirements, including, but not limited to: registration and listing (21

6

Page 2 - Dr. Jen, Ke-Min

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 (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 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. 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/Reportal/roblem/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 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,

Felipe Aquel -S

Carlos Pena, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

7

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K131720

Device Name

HIVOX Self-Adhesive Electrode Gel Pads

Indications for Use (Describe)

HIVOX self-adhesive electrode gel pads are intended for use as disposable, conductive adhesive interface between the patient's skin and the electrical stimulator. The device is a gel pad for use with an electrode itself.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

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

- Date: 2014.07.25 17:34:13 04'00'

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