ZMI Self-Adhesive Electrodes

K180865 · Zmi Electronics , Ltd. · GXY · Jun 28, 2018 · Neurology

Device Facts

• Record ID: K180865
• Device Name: ZMI Self-Adhesive Electrodes
• Applicant: Zmi Electronics , Ltd.
• Product Code: GXY · Neurology
• Decision Date: Jun 28, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ZMI Self-adhesive electrodes are intended for use as a reusable, conductive adhesive interface between the patient's skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrodes are for OTC (Over-The-Counter) or Prescription use.

Device Story

ZMI Self-Adhesive Electrodes serve as a conductive interface between a patient's skin and electrical stimulators (TENS, EMS, IF, PGF). The device consists of a multi-layer structure: an insulation backing (fabric/foam), a conductive film (silver-coated carbon or aluminum foil), and a biocompatible conductive hydrogel. It connects to stimulators via leadwires, snap buttons, or magnetic buttons. Used in clinical or home settings, the device is applied by the patient or clinician to the skin to transmit electrical current for therapy. The output is the delivery of stimulation current to the target tissue, which the healthcare provider or patient monitors via the stimulator's settings. The device facilitates therapeutic electrical stimulation, potentially benefiting patients by providing pain relief or muscle stimulation. It is a passive component; it does not generate or control the stimulation parameters itself.

Clinical Evidence

No clinical data. Bench testing only. Evaluated AC impedance, current dispersion, repeated skin adhesion, and electrical connection retention force. Biocompatibility testing (cytotoxicity, irritation, sensitization) performed per ISO 10993-1.

Technological Characteristics

Three-layer construction: insulation backing (fabric/foam), conductive film (silver-coated carbon/aluminum foil), and conductive hydrogel. Electrical connection via leadwire, snap button, or magnetic button. Non-sterile, reusable, single-patient use. AC impedance <200 ohms. Biocompatible materials per ISO 10993.

Indications for Use

Indicated for adult patients requiring electrical stimulation therapy (TENS, EMS, IF, or PGF) via a reusable, conductive adhesive interface between the skin and a stimulation device. Suitable for OTC or prescription use.

Regulatory Classification

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.

Predicate Devices

• Wandy self-adhesive electrodes (K132998)
• Adhesive Electrodes (K160138)

Reference Devices

• Legally marketed device (K172876)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The Department of Health and Human Services logo is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the words "U.S. Food & Drug Administration" in blue as well.

June 28, 2018

ZMI Electronics, Ltd. Yuta Lee President 6F-1, 286-4, Shin Ya Road Kaohsiung, 806 TW

Re: K180865

Trade/Device Name: ZMI Self-Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: February 23, 2018 Received: April 2, 2018

Dear Yuta Lee:

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 of medical device-related adverse events) (21 CFR 803); good

{1}------------------------------------------------

manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

William J. Heetderks -S 2018.06.28 13:45:12 -04'00'

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

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K180865

Device Name ZMI Self-Adhesive Electrodes

#### Indications for Use (Describe)

ZMI Self-adhesive electrodes are intended for use as a reusable, conductive interface between the patient's skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrodes are for OTC (Over-The-Counter) or Prescription use.

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

| <div> <span style="font-size: 10pt;"> <b> </b> </span> <span style="font-size: 10pt;">Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> |
|--------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 10pt;"> <b> </b> </span> <span style="font-size: 10pt;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510k Summary

### Device 510k number: K180865

### Submitter Information

ZMI Electronics, Ltd. 6F-1, 286-4, Shin-Ya Road, Kaohsiung, Taiwan 806 Tel: [phone] Fax: [phone] Contact person: Wayne Chen, Sales Manager Date: June 6, 2018

### FDA Registration Number

Owner/Operator Number: 9035676 Establishment Registration Number: 9617486

### Regulatory Information

Trade name: ZMI Self-Adhesive Electrodes Common Name: Reusable Neurostimulation Electrodes Classification Name: Electrodes, cutaneous Regulation Number: 882.1320 Product Code: GXY Classification: Class II

### Predicate Devices:

K132998 Wandy self-adhesive electrodes (WANDY Rubber Industrial Co., Ltd.) *Primary Predicate K160138 Adhesive Electrodes (GMDASZ Manufacturing Co., Ltd.)

### Device Description

ZMI Self-adhesive electrodes provide a means for establishing electrical contact between the lead connected to a TENS, EMS or NMES stimulation device and the skin, and are multi-layer, reusable, flexible structures composed of laminated materials commonly used in the application:

Top laver: Insulation material: Fabric/foam/tan fabric Middle layer: Conductive film (Silver coated Carbon film/Aluminum foil film) Bottom layer: Biocompatible self-adhesive conductive hydrogel Connection: Leadwire/snap button/magnetic button

The electrodes are designed for single-patient & multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin.

#### Indications for Use

ZMI Self-adhesive electrodes are intended for use as a reusable, conductive adhesive interface between the patient's skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current. The electrodes are for OTC (Over-The-Counter) or Prescription use.

{4}------------------------------------------------

### Comparison to predicate device:

| Element of Comparison | Subject Device (K180865) | Predicate Device (K132998) | Comment |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | ZMI Electronics, Ltd. | Wandy Rubber Industrial Co. Ltd | N/A |
| Device Name | ZMI Self-adhesive electrodes | Wandy Self-adhesive electrodes | N/A |
| Model name | SAE Type | Type A, Type P, Type M | N/A |
| Shape | Round, Rectangular, Square, Oval, and Butterfly | Round, Rectangular, Square, Oval, and Butterfly | Same |
| Color | White, Red, Black, and Tan | White, Red, Black, and Tan | Same |
| Regulation Number | 882.1320 | 882.1320 | Same |
| Product Code | GXY | GXY | Same |
| Classification Name | Cutaneous electrode | Cutaneous electrode | Same |
| Intended Use | ZMI Self-adhesive electrodes are intended for as a reusable, conductive adhesive interface between the patient's skin and the marketed electrical stimulators (i.e. TENS (Transcutaneous Electrical Nerve Stimulation), EMS (Electrical Muscular Stimulation), IF (Interferential) or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use. | Wandy Self-adhesive Electrode is intended to transmit electrical current to patient skin for TENS (Transcutaneous Electrical Nerve- Stimulation) and EMS (Electrical muscular Stimulation) application, for OTC (Over-the- Counter) or Prescription use. The electrodes are used for adults only. | SE |
| OTC or Prescription | OTC and Prescription | OTC and Prescription | Same |
| Target Population | General [Adult] | General [Adult] | Same |
| Design Feature | Three layers:<br>1. Insulation backing material: Fabric/Foam/Tan fabric<br>2. Conductive film: Aluminum foil film /Carbon film/Carbon film coated with silver/<br>3. Conductive hydrogel | Three layers:<br>1. Insulation backing material: Woven Fabric/Foam<br>2. Conductive film: Aluminum foil film /Carbon film/Carbon film coated with silver/<br>3. Conductive hydrogel | 1. SE The fabric and foam are commonly used for insulation cover on adhesive electrodes. The fabric material includes the synthetic fibers and natural fibers. Both fiber types can fulfill the insulation property, which won't raise any concerns of safety or effectiveness.<br>2. Same<br>3. Same |
| Electrical Connection | Leadwire<br>Snap button<br>Magnetic button | Leadwire<br>Snap button | Same<br>Same<br>SE The magnetic button provides another type of |
| | | | source of stimulation<br>current via magnetic<br>force among male and<br>female connectors. This<br>is similar to the other<br>connection methods like<br>leadwires & snap<br>buttons. No new<br>concerns of safety or<br>effectiveness are raised. |
| Lead Wire<br>connector | Leadwire connector .080"<br>(2mm) female socket<br>connector | Leadwire connector .080"<br>(2mm) female socket<br>connector | Same |
| Non-sterile | Non-sterile | Non-sterile | Same |
| Reusable | Reusable | Reusable | Same |
| Packaging | Re-sealable bag packed | Re-sealable bag packed | Same |
| Adhesive Type | Self-adhesive | Self-adhesive | Same |
| Biocompatibility | Complies with ISO10993 | Complies with ISO10993 | Same |
| A.C. Impedance | <200 ohms | <200 ohms | Same |
| Force required to<br>remove wire from<br>electrode | More than 6 pounds of<br>force | More than 6 pounds of<br>force | Same |
| Single Patient<br>Use | Yes | Yes | Same |

{5}------------------------------------------------

## Comparison to predicate device:

| Element of<br>comparison | Subject Device<br>(K180865) | Predicate Device<br>(K160138) | Justification |
|--------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| comparison | | | |
| Company | ZMI Electronics, Ltd. | GMDASZ Manufacturing<br>Co., Ltd. | N/A |
| Device Name | ZMI Self-adhesive<br>electrodes | Adhesive Electrodes | N/A |
| Model Name | SAE Type | OCWN1005, OCWN1007,<br>OCWN2505, OCWN2509,<br>OACWN1005,<br>OACWN1007,<br>OACWN2505,<br>OACWN2509 | N/A |
| Shape | Round, Rectangular,<br>Square, Oval, and Butterfly | Round and Rectangular | SE<br>The shape and size are<br>related to the treatment<br>area. Smaller area may<br>cause higher current<br>density, which leads to<br>discomfort and burns. |
| Color | White, Red, Black, and Tan | Tan | The current densities for<br>any shaped electrodes<br>exceeding 2mA r.m.s<br>/cm² may require the<br>special attention of the<br>user. The color is mainly<br>for identification and<br>marketing purpose, and<br>does not raise any new<br>concerns of safety or<br>effectiveness. |

{6}------------------------------------------------

| Regulation<br>Number | 882.1320 | 882.1320 | Same |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | GXY | GXY | Same |
| Classification<br>Name | Cutaneous electrode | Cutaneous electrode | Same |
| Intended Use | ZMI Self-adhesive<br>electrodes are intended for<br>as a reusable, conductive<br>adhesive interface between<br>the patient's skin and the<br>marketed electrical<br>stimulators (i.e. TENS<br>(Transcutaneous Electrical<br>Nerve Stimulation), EMS<br>(Electrical Muscular<br>Stimulation), IF<br>(Interferential) or PGF<br>(Pulsed Galvanic<br>Stimulation) for transmitting<br>electrical current, for OTC<br>(Over-The-Counter) or<br>Prescription use. | The adhesive electrodes<br>are intended for as a<br>reusable, conductive<br>adhesive interface between<br>the patient's skin and the<br>marketed electrical<br>stimulators (i.e. TENS<br>(Transcutaneous Electrical<br>Nerve Stimulation), EMS<br>(Electrical Muscular<br>Stimulation), IF<br>(Interferential) or PGF<br>(Pulsed Galvanic<br>Stimulation) for transmitting<br>electrical current, for OTC<br>(Over-The-Counter) or<br>Prescription use. | Same |
| OTC or<br>Prescription | OTC and Prescription | OTC and Prescription | Same |
| Target Population | General [Adult] | General [Adult] | Same |
| Design Feature | Three layers:<br>1. Insulation backing<br>material: Fabric/Foam/Tan<br>fabric<br>2. Conductive film:<br>Carbon film/Carbon film<br>coated with silver/Aluminum<br>foil film<br>3. Conductive hydrogel | Three layers:<br>1. Insulation backing<br>material:<br>Fabric/Foam/Tan fabric<br>2. Conductive film:<br>Carbon film/Carbon film<br>coated with silver/Aluminum<br>foil film<br>3. Conductive hydrogel | Same |
| Electrical<br>Connection | Leadwire<br>Snap button<br>Magnetic button | Leadwire | SE<br>The snap button and the<br>magnetic button provide<br>different types of<br>physical contact with the<br>source of stimulation<br>current via spring<br>tension or magnetic<br>force among male and<br>female connectors.<br>Either method is similar<br>to the lead wire<br>connection providing the<br>friction to create the<br>physical contact. |
| Lead Wire<br>connector | Leadwire connector .080"<br>(2mm) female socket<br>connector | Leadwire connector .080"<br>(2mm) female socket<br>connector | Same |
| Non-sterile | Non-sterile | Non-sterile | Same |
| Reusable | Reusable | Reusable | Same |
| Packaging | Re-sealable bag packed | Re-sealable bag packed | Same |
| Self-adhesive | Self-adhesive | Self-adhesive | Same |
| A.C. Impedance | <200 ohms | <300 ohms | SE |
| Force required to<br>remove wire from<br>electrode | More than 6 pounds of<br>force | More than 6 pounds of<br>force | Same |
| Single Patient<br>Use | Yes | Yes | Same |

6F-1, 286-4, Shin-Ya Road, Kaohsiung, Taiwan 806; TEL[phone]; FAX[phone]

{7}------------------------------------------------

## Performance

ZMI self-adhesive electrodes are composed of insulation fabric, conductive carbon film, and conductive hydrogel. Electrical performance was evaluated by measuring the AC impedance and current dispersion across the surface of the electrodes. Adhesive performance was evaluated by performing a repeated skin adhesion test. Electrode stability was evaluated by assessing electrical performance under normal use conditions. The electrode material should be reliable to resist physical and chemical breakdown as a result of conducting electrical current. To assess this, ZMI self-adhesive electrodes were tested to ensure they fulfilled the specifications after a period of the conventional use. No shelf-life testing was conducted. As the storage conditions could affect the shelf-life, it is recommended to always keep electrodes cool and to avoid exposure of the surface to heat and humidity. The electrical properties of the connectors were evaluated by measuring the resistance of the connection retention retention force.

The subject device has a magnetic button for electrical connection, which differs from the two predicate devices. The conventional method of electrical connection of adhesive electrodes is to use either a snap button or lead wire to provide physical contact with the source of stimulation current via the spring tension or the friction between male and female connectors. The magnetic button applies similar concepts, providing physical contact with the source of stimulation current via magnetic force among male and female connectors. The new technological characteristic of the subject device with the magnetic button is identical to the legally marketed device under K172876.

### Biocompatibility

Biocompatibility evaluation for ZMI self-adhesive electrodes was done according FDA Good Manufacturing Practice & ISO 10993-1. The following tests were identified and done:

- . Cytotoxicity
- Irritation
- . Sensitization

#### Clinical

No clinical tests were needed.

#### Conclusion

Verification testing of the ZMI self-adhesive electrical and mechanical tests to show that it meets its target specifications over a range of operating and storage conditions. Verification and performance testing further demonstrated that it meets user needs as reflected in the functional specification.

The submitted ZMI self-adhesive electrodes have intended use and similar technological characteristics as the predicate devices. Moreover, information contained in the submission supplied demonstrates that any differences in their characteristics do not raise new concerns of safety or effectiveness. Thus, the submitted adhesive electrodes are substantially equivalent to the predicate devices.