Self-adhesive Electrode

K222453 · Guangdong Comytens Medical Technology Co., Ltd. · GXY · Nov 4, 2022 · Neurology

Device Facts

• Record ID: K222453
• Device Name: Self-adhesive Electrode
• Applicant: Guangdong Comytens Medical Technology Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: Nov 4, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Self-Adhesive Electrode is intended for 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 or IFC(Interferential current),or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.

Device Story

Self-adhesive electrodes function as conductive interface between patient skin and electrical stimulators (TENS, EMS, IFC, PGF). Device consists of multi-layer structure: fabric/foam backing, conductive film (carbon/aluminum), and biocompatible conductive hydrogel. Connects to stimulators via lead wires, snap buttons, or magnetic buttons. Used in clinical or home settings; applied by patient or clinician. Device transmits electrical current from stimulator to patient skin; adhesive hydrogel secures electrode without external fasteners. Reusable design allows multiple applications on single patient. Benefits include non-invasive delivery of electrical stimulation for therapeutic purposes.

Clinical Evidence

No clinical data. Bench testing only, including electrical impedance, adhesion force, mechanical connector testing, and accelerated aging per ASTM F1980. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, irritation).

Technological Characteristics

Multi-layer construction: fabric/foam backing, conductive film (silver-coated carbon/carbon/aluminum), and biocompatible conductive hydrogel. Connectivity: lead wire (2mm/2.5mm socket), snap button, or magnetic button. Impedance <200 ohms. Non-sterile. Complies with IEC 60601-1 (basic safety) and ISO 10993 (biocompatibility).

Indications for Use

Indicated for use as a reusable, conductive interface between patient skin and electrical stimulators (TENS, EMS, IFC, PGF) for general adult populations. Suitable for both OTC and 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

• ZMI Self-adhesive (K180865)

Submission Summary (Full Text)

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November 4, 2022

Guangdong Comytens Medical Technology Co., Ltd Mr. Amos Zou RA Manager Building A-102, No. 24, Jiangjunmao Industrial Zone Wulian, Longgang District Shenzhen, Guangdong 518116 China

Re: K222453

Trade/Device Name: Self-adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: August 12, 2022 Received: August 15, 2022

Dear Mr. Amos Zou:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Tushar Bansal -S

Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K222453

Device Name Self-adhesive Electrode

### Indications for Use (Describe)

Self-Adhesive Electrode is intended for 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 or IFC(Interferential current),or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|-----------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 16px;">☑</span> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 16px;">☑</span> |

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# 510(K)SUMMARY

#### 1. Submitter of 510(K):

| Sponsor | |
|-------------------|-----------------------------------------------------------------------------------------------------------------------|
| Company Name: | Guangdong Comytens Medical Technology Co.,Ltd |
| Address: | Building A-102, No. 24, Jiangjunmao Industrial Zone, Wulian, Longgang District ,<br>Shenzhen, Guangdong, China 518116 |
| Contact person: | Deng Jiuzhen |
| TEL: | [phone] |
| FAX: | / |
| E-mail: | [e-mail] [e-mail] |
| Date of Prepared: | Nov, 3 2022 |

## Application Correspondent:

| Company Name: | Guangdong Comytens Medical Technology Co.,Ltd |
|-------------------|-----------------------------------------------------------------------------------------------------------------------|
| Address: | Building A-102, No. 24, Jiangjunmao Industrial Zone, Wulian, Longgang District ,<br>Shenzhen, Guangdong, China 518116 |
| Contact person: | Amos Zou |
| TEL: | [phone] |
| E-mail: | [e-mail] |
| Date of Prepared: | Nov, 3 2022 |

#### 2. Proposed Device and code:

| Device Trade Name: | Self-Adhesive Electrode |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Model Series | Self-Adhesive Electrodes with lead wire;<br>Self-Adhesive Electrodes with Snap/Magnetic connector;<br>Self-Adhesive Electrode Pads |
| Regulation Medical Specialty | Neurology |

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| Product Code: | GXY |
|-------------------|-----------------|
| Regulation number | 21 CFR 882.1320 |
| Device Class | II |
| 510(K) Number | K222453 |

#### Predicate Device: 3.

| 510(K) | Trade Name | Submitter | Product Code |
|---------|-------------------|-----------------------|--------------|
| K180865 | ZMI Self-adhesive | ZMI Electronics, Ltd. | GXY |

#### Description of Proposed Device: 4.

Self-Adhesive Electrodes are composed of conductive carbon film and adhesive Electrodes composed of Aluminum foil film,Adhesive Electrodes manufactured by Comytens are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:

| No. | Description | Material Composition |
|-----|-------------------------------|----------------------------------------------------------------------------|
| 1 | Top layer | Fabric/Foam/ Tan fabric |
| 2 | Middle layer | Conductive film (Silver coated Carbon Film/Carbon film/Aluminum foil film) |
| 3 | Bottom layer | Biocompatible self-adhesive conductive hydrogel |
| 4 | Connection | Leadwire/snap button/magnetic button |
| 5 | double sides<br>adhesive tape | which is used for attaching the non-woven fabrics and conducting film |
| 6 | Release liner | plastic film is a protective layer for the hydrogel. |

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.

For the electrical connection, Comytens provides lead wire type and snap button/Magnetic button type:

- Leadwire assembly:
The electrode is connected to the electrical stimulator by lead wire, at least 40 mm long wire with a standard connector: 0.08"/0.1"(2mm/2.5mm) diameter female socket connector with insulating outer. By design, the insulated outer jacket prevents the connection to earth or hazardous voltages. The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR part 898 by testing under ANSI/AAMI ES60601-1, subclause 8.5.2.3.

- Snap button/Magnetic button assembly:
With 2.5~5mm diameter male socket. The snap button and the magnetic button provide different types of physical contact with the source of stimulation current via spring tension or magnetic force among male and femaleconnectors. Either method is similar to the lead wire connection providing the friction to create the physicalcontact.

#### 5. Intended for Use

Self-Adhesive Electrode is intended for 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 or IFC(Interferential current), or PGF (Pulsed Galvanic Stimulation) for transmitting electrical current, for OTC (Over-The-Counter) or Prescription use.

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#### 6. Technical and Performance

The following table compares the device to the predicate device with basic technological characteristics.

Comparison to predicate device:

| Element of<br>Comparison | Subject Device | Predicate Device | Comm<br>ent |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| 510(k) | K222453 | K180865 | N/A |
| Company | Guangdong Comytens Medical<br>Technology Co.,Ltd | ZMI Electronics, Ltd. | N/A |
| Device Name | Self-Adhesive Electrodes | ZMI Self-adhesive electrodes | N/A |
| Model name | ● Self-Adhesive Electrodes with leadwire;<br>● Self-Adhesive Electrodes with Snap<br>/Magnetic connector;<br>● Self-Adhesive Electrode Pads | SAE Type | N/A |
| Shape | Square(40*40mm) | Round, Rectangular, Square, Oval, and<br>Butterfly | similar<br>1# |
| Color | White, Red, Black, and Tan | White, Red, Black, and Tan | Same |
| Regulation<br>Number | 882.1320 | 882.1320 | Same |
| Product Code | GXY | GXY | Same |
| Classification<br>Name | Cutaneous electrode | Cutaneous electrode | Same |
| Intended Use | Self-Adhesive Electrode is intended for as<br>a reusable, conductive adhesive interface<br>between the patient's skin and the<br>marketed electrical stimulators (i.e.TENS<br>(Transcutaneous Electrical Nerve<br>Stimulation), EMS (Electrical Muscular<br>Stimulation), IF or IFC(Interferential<br>current), RUSS(Russian stimulation),<br>MIC(Microcurrent) or PGF (Pulsed<br>Galvanic Stimulation) for transmitting<br>electrical current, for OTC (Over-The-<br>Counter) or Prescription use. | ZMI Self-adhesive electrodes are<br>intended for as a reusable, conductive<br>adhesive interface between the patient's<br>skin and the marketed electrical<br>stimulators (i.e. TENS (Transcutaneous<br>Electrical Nerve Stimulation), EMS<br>(Electrical Muscular Stimulation), IF<br>(Interferential) or PGF (Pulsed Galvanic<br>Stimulation) for transmitting electrical<br>current, for OTC (Over-The-Counter) or<br>Prescription use. | Same |
| OTC or<br>Prescription | OTC and Prescription | OTC and Prescription | Same |
| Target<br>Population | General [Adult] | General [Adult] | Same |
| Design<br>Feature | Six layers:<br>1. Insulation backing material:<br>Fabric/Foam/Tan fabric<br>2. Conductive film: Aluminum foil film | Three layers:<br>1. Insulation backing material:<br>Fabric/Foam/Tan fabric<br>2.Conductive film: Aluminum foil | similar<br>2# |
| | /Carbon film/Carbon film coated with<br>silver/<br>3.Conductive hydrogel<br>4.Connection<br>5.double sides adhesive tape<br>6.Release liner | film/Carbon film/Carbon film coated with<br>silver/<br>3.Conductive hydrogel | |
| Electrical<br>Connection | Leadwire<br>Snap button<br>Magnetic button | Leadwire<br>Snap button<br>Magnetic button | Same |
| Lead Wire<br>connector | .080"/0.1"(2mm/2.5mm) female socket<br>or Pin connector | .080" (2mm) female socket connector | similar<br>3# |
| Non-sterile | Non-sterile | Non-sterile | Same |
| Reusable | Reusable | Reusable | Same |
| Packaging | Re-sealable bag packed | Re-sealable bag packed | Same |
| Adhesive<br>Type | Self-adhesive | Self-adhesive | Same |
| Biocompatibi<br>lity | Complies with ISO10993 | Complies with ISO10993 | Same |
| A.C.<br>Impedance | <200 ohms | <200 ohms | Same |
| Force<br>required to<br>remove<br>wire from<br>electrode | More than 6 pounds of force | More than 6 pounds of force | Same |
| Single<br>Patient Use | Yes | Yes | Same |

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Comparison in Detail(s):

1#: The shape and size are related to the treatment area may cause higher current density, which leads to discomfort and burns. The current densities for any shaped electrodes exceeding 2mA r.m.s/cm2 may require the special attention of the user. The color is mainly for identification and marketing purpose, and does not raise any new concerns of safety or effectiveness.

If the subject device is manufactured from the identical raw materials manufacturing processes as a predicate device with the same type and duration of tissue contact, and any changes in geometry are not expected to impact the biological response, this is typically sufficient to establish substantially equivalent biocompatibility.

2#: The subject device and predicate device are similar in construction. They both contain three basic components: a nonconductive top layer, a patient contacting layer, a carbondispersion pad middle layer, and; while the Self-Adhesive Electrode also contains three additional layer:conductive carbon fiber lead wire (or snap for Magnetic Style Electrode),double sides adhesive tape which is used for attaching the non-woven fabrics and conducting film,and plastic film is a protective layer for the hydrogel. Which the differences will not affectiveness of the Self-Adhesive Electrode.

3#: The snap button and the magnetic button provide different types of physical contact with the source of stimulation current via spring tension or magnetic force among male and female connectors. Either method is similar to the lead wire connection providing the friction to create the physical contact.

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## 7. Performance Testing:

## Test Summary:

To establish substantial equivalence to the identified predicate devices, we performed the following tests on the subject device, Adhesive Electrodes TS serial,and the testing results provide evidence that the device complies with the applicable standards requirement and it is substantially equivalent to the predicate devices. Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.

## 7.1 Non-Clinical Data:

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrate that the proposed device complies with the following standards:

## 7.2 Biocompatibility testing

The biocompatibility evaluation for the Self-Adhesive Electrode conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is contacting for duration of less than 24 hours. And the testing included the following tests:

- Cytotoxicity
- Skin Sensitization
- . Skin Irritation

## 7.3 Safety and EMC

To verify the basic safety and essential performance of the subject device, weperformed the test noted below: - IEC60601-1:2005+AMD1:2012+AMD2:2020; Medical electrical equipment - Part 1: General requirementsfor basic safety and essential performance

The submitted sample(s) complied with the requirements of IEC 60601-1:2005+AMD1:2012+AMD2:2020, Cl.8.5.2.3

## 7.4 Bench Testing

Bench tests were conducted on Self-Adhesive Electrode to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

1. Electrical & Impedance Tests

The Self-Adhesive Electrode was tested to assure the current is equally distributed. The Self-Adhesive Electrode was also tested for Impedance to assure proper electrical connection to the skin.

2. Adhesion tests

The Self-Adhesive Electrode was tested for initial adhesion force after using multiple times. 3. Connector & Mechanical tests

The Self-Adhesive Electrode has a Snap or magnetic surface with the purpose to clamp the Self-Adhesive Electrode. This connection was tested to assure multiple use and also to assure the TENS stay fixed to the Self-Adhesive Electrode during use.

4. Packaging testsReal-Time Shelf Life Test Report

The Self-Adhesive Electrode was tested for storage conditions:

· The Self-Adhesive Electrode should not be stored at temperatures lower than 41°E(+5°C) or higher than 80.6°F (+27°C). 5. Accelerated Aging

The Self-Adhesive Electrode was tested for accelerate aging in worst storage condition to assure within the expiration date the electrode function as expected.

- ASTM F1980 (Reapproved 2016), Standard guide for accelerated aging of sterile barrier systems for medical devices. (Sterility)

## 7.5 Clinical data:

No clinical testing was performed

## 7.6 Summarv

Based on the non-clinical and clinical performance as documented in the device devices were found to have a safety and effectiveness profile that is similar to the predicate device.

## 8. Conclusions:

The proposed device has the same intended use and similar characteristics as the predicate device, Meanwhile, performance testing, bench testing, and safety report documentation supplied in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Guangdong Comytens Medical Technology Co.,Ltd. maintains that the Self-Adhesive Electrode is substantially equivalent to the

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predicate device in indications for use, patient population, and environment for use, technology characteristics,
specifications / performance and compliance with internation