Adhesive Electrodes

K160138 · Gmdasz Manufacturing Co., Ltd. · GXY · Aug 11, 2016 · Neurology

Device Facts

• Record ID: K160138
• Device Name: Adhesive Electrodes
• Applicant: Gmdasz Manufacturing Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: Aug 11, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 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 electrode is for OTC (Over-The-Counter) or Prescription use.

Device Story

Adhesive electrodes function as a conductive interface between patient skin and electrical stimulators (TENS, EMS, IF, PGF); device consists of multi-layer flexible structure: insulating backing (fabric/foam), conductive film (carbon, silver-coated carbon, or aluminum foil), and biocompatible self-adhesive conductive hydrogel; electrodes connect to stimulators via lead wire with .080" recessed female terminal; single-patient, multiple-application use; no external securing materials required due to adhesive hydrogel; device transmits electrical current to patient; healthcare provider or patient applies electrodes to skin; output is electrical stimulation; benefits include non-invasive pain management or muscle stimulation.

Clinical Evidence

No clinical data. Bench testing only, including safety, adhesion, current dispersion, reusability, and stability tests performed in accordance with EC12/EC53 standards.

Technological Characteristics

Multi-layer flexible structure: insulating backing (fabric/foam/tan fabric), conductive film (carbon film, silver-coated carbon, or aluminum foil), and biocompatible self-adhesive conductive hydrogel. Protective PET liner. Lead wire connection with .080" female socket. Non-sterile. Complies with ISO10993 for biocompatibility and 21 CFR Part 898 for lead wire assembly.

Indications for Use

Indicated for use as a reusable, conductive adhesive interface for transmitting electrical current from marketed electrical stimulators (TENS, EMS, IF, or PGF) to the patient's skin. 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

• GMDASZ TENS Electrodes (K092546)
• Wandy self-adhesive electrodes (K132998)

Submission Summary (Full Text)

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Image /page/0/Picture/1 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

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

August 11, 2016

GMDASZ Manufacturing Co., Ltd % Charles Mack Principal Engineer IRC 2250 Duportail Street, M275 Richland, Washington 99352

Re: K160138

Trade/Device Name: Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: June 28, 2016 Received: July 13, 2016

Dear Mr. Mack:

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 (reporting of medical device

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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" (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 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,

# Michael J.Hoffmann -A

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

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# Indications for Use

510(k) Number (if known) K160138

Device Name Adhesive Electrodes

Indications for Use (Describe)

The 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 electrode is for OTC (Over-The-Counter) or Prescription use.

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

| <div> <span> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510k Summary

Device 510k number: K160138

#### Submitter Information:

GMDASZ Manufacturing Co., Ltd. Room E1308, Xihaimingzhu Building, Taoyuan Road , Nanshan District, ShenZhen City, Guangdong Province, P.R. China. Postcode: 518052 Tel: [phone] Fax: [phone] Contact person: Mr. Xiangjie Zhang (General Manager)

#### FDA Registration Number:

Owner/Operator Number: 10031210 Establishment Registration Number: 3008197884

#### Regulatory Information:

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

## Predicate Devices:

| K092546 | GMDASZ TENS Electrodes (GMDASZ Manufacturing Co., Ltd.) |
|---------|--------------------------------------------------------------------|
| K132998 | Wandy self-adhesive electrodes (WANDY Rubber Industrial Co., Ltd.) |

## Device Description:

Adhesive Electrodes are composed of conductive carbon film, and carbon film coated with silver are identical in technological characteristics compared to our own previous 510K cleared electrodes in K092546, so this premarket notification supports a change to the product labeling only to allow the product to be sold for over-the-counter (OTC) use and prescription use.

Adhesive Electrodes composed of Aluminum foil film, are technologically equivalent to the predicate devices - K132998 Wandy self-adhesive electrodes for over-the-counter (OTC) use and prescription use.

Adhesive Electrodes manufactured by GMDASZ are multi-layer reusable, flexible structures composed of laminated materials commonly used in this application:

First layer: Insulating backing material: Fabric/foam/tan fabric Second layer: Conductive film/Carbon film coated with silver/Aluminum foil film Third layer: Biocompatible self-adhesive conductive hydrogel Protective liner: PET

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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. The electrode is connected to the electrical stimulator by lead wire, with a standard .080" recessed female terminal with insulating outer jacket. By design, the insulated outer jacket prevents the conductive connection to earth or hazardous voltages. Wire assembly is incompliance with FDA performance standard 21 CFR Part 898.

## Indications for Use:

The 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 electrode is for OTC (Over-The-Counter) or Prescription use.

| Element of<br>comparison | Subject Device<br>(K160138) | Predicate Device<br>(K092546) | Justification |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | GMDASZ Manufacturing<br>Co., Ltd. | GMDASZ Manufacturing<br>Co., Ltd. | Same |
| Device Name | Adhesive Electrodes | GMDASZ TENS<br>Electrodes | N/A |
| Model Name | OCWN1005, OCWN1007,<br>OCWN2505, OCWN2509,<br>OACWN1005,<br>OACWN1007,<br>OACWN2505,<br>OACWN2509 | CWN1005, CWN1007,<br>CWN2505, CWN2509,<br>ACWN1005,<br>ACWN1007,<br>ACWN2505,<br>ACWN2509 | N/A |
| Regulation Number | 882.1320 | 882.1320 | Same |
| Product Code | GXY | GXY | Same |
| Classification<br>Name | Cutaneous electrode | Cutaneous electrode | Same |
| OTC or<br>Prescription | OTC and Prescription | Prescription | Predicate device<br>K132998 (below)<br>is both OTC and<br>Rx only.<br>Additionally, the<br>labeling has<br>defined restricted<br>areas of<br>application,<br>exactly like the<br>predicate device<br>K132998. |
| Intended Use | The adhesive electrodes | The GMDASZ TENS | Similar |
| | are intended for as a | Electrodes are intended | |
| | reusable, conductive | for use as a reusable, | |
| | adhesive interface between | conductive adhesive | |
| | the patient's skin and the | interface between the | |
| | marketed electrical | patient's skin and the | |
| | stimulators (i.e. TENS | Electrical Stimulator. | |
| | (Transcutaneous Electrical | GMDASZ's reusable | |
| | Nerve Stimulation), EMS | electrodes are designed | |
| | (Electrical Muscular | and intended to be used | |
| | Stimulation), IF | with marketed, Electrical | |
| | (Interferential) or PGF | Stimulators i.e. TENS | |
| | (Pulsed Galvanic | (Transcutaneous | |
| | Stimulation) for | Electrical Nerve | |
| | transmitting electrical | Stimulation), EMS | |
| | current. The electrode is | (Electrical Muscular | |
| | for OTC (Over-The- | Stimulation), IF | |
| | Counter) or Prescription | (Interferential) or PGF | |
| | use. | (Pulsed Galvanic | |
| | | Stimulation). | |
| | | | |
| | | The electrotherapy | |
| | | electrodes are intended to | |
| | | be used to apply electrical | |
| | | stimulation current to the | |
| | | patient's skin. | |
| Design Feature | Three layers: | Three layers: | 1) Same<br>2) Same except<br>subject device<br>has the option of<br>an Aluminum<br>foil film. The<br>Aluminum foil<br>film is used as a<br>conductive film<br>in predicate<br>K132998<br>(below).<br><br>3) Same |
| | 1. Insulation backing | 1. Insulating backing | |
| | material: | material: | |
| | Fabric/Foam/Tan fabric | Fabric/Foam/Tan fabric | |
| | | | |
| | 2. Conductive film: | 2. Conductive plastic | |
| | Carbon film/Carbon film | film: Carbon film/ Carbon | |
| | coated with | film coated with silver | |
| | silver/Aluminum foil film | | |
| | | 3. Conductive hydrogel | |
| | 3. Conductive hydrogel | (A, T or U gel) | |
| | (A, T or U gel) | | |
| | | | |
| Electrical<br>Connection | Leadwire | Leadwire | Same |
| | | | |
| Protective Liner | PET | PET | Same |
| Lead Wire<br>connector | Leadwire connector .080"<br>female socket connector | Leadwire connector .080"<br>female socket connector | Same |
| | | | |
| | | | |
| Reusable | Reusable | Reusable | Same |
| Packaging | Re-sealable bag packed | Re-sealable bag packed | Same |
| Self-adhesive | Self-adhesive | Self-adhesive | Same |
| Biocompatibility | Complies with ISO10993 | Complies with ISO10993 | Same |
| A.C. Impedance | <300 ohms | <300 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 Use | Single Patient Use | Single Patient Use | Same |

#### Comparison to predicate device:

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| Element of | Subject Device | Predicate Device | Comment |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| comparison | (K160138) | (K132998) | |
| Company | GMDASZ Manufacturing<br>Co., Ltd. | Wandy Rubber Industrial<br>Co. Ltd | N/A |
| Device Name | Adhesive Electrodes | Wandy Self-adhesive<br>electrodes | N/A |
| Model name | LWN1005, LWN1007,<br>LWN2505, LWN2509 | Type A, Type P, Type M | N/A |
| Regulation Number | 882.1320 | 882.1320 | Same |
| Product Code | GXY | GXY | Same |
| Classification<br>Name | Cutaneous electrode | Cutaneous electrode | Same |
| Intended 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<br>transmitting electrical<br>current. The electrode is<br>for OTC (Over-The-<br>Counter) or Prescription<br>use. | Wandy Self-adhesive<br>Electrode is intended to<br>transmit electrical current<br>to patient skin for TENS<br>(Transcutaneous<br>Electrical Nerve-<br>Stimulation) and EMS<br>(Electrical muscular<br>Stimulation) application,<br>for OTC (Over-the-<br>Counter) or Prescription<br>use. The electrodes are<br>used for adults only. | Similar |
| OTC or<br>Prescription | OTC and Prescription | OTC and Prescription | Same |
| Design Feature | Three layers<br>1. Insulation backing<br>material: Fabric/Foam/Tan<br>fabric<br><br>2. Conductive film:<br>Carbon film/Carbon film<br>coated with<br>silver/Aluminum foil film<br><br>3. Conductive hydrogel<br>(A, T or U gel) | Three layers:<br>1. Insulating backing<br>material: Woven<br>Fabric/Foam<br><br>2. Conductor:<br>Aluminum/Carbon<br><br>3. Conductive hydrogel<br>(A, T or U gel) | 1) Doesn't<br>impact safety<br>and effectiveness<br>of subject device<br><br>2) Subject device<br>contains<br>aluminum foil as<br>a conductive<br>film.<br>Predicate<br>includes 'Type<br>A' model which<br>has used<br>aluminum foil as<br>a conductive<br>device<br><br>3) Same |
| Electrical<br>Connection | Leadwire | Leadwire or Snap | Similar<br><br>Subject device<br>does not have<br>snap style<br>connection but<br>this shouldn't<br>impact its safety<br>or effectiveness. |
| Protective Liner | PET | PET | Same |
| Lead Wire<br>connector | Leadwire connector .080"<br>female socket connector | Leadwire connector .080"<br>female socket 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 |
| Biocompatibility | Complies with ISO10993 | Complies with ISO10993 | Same |
| A.C. Impedance | <300 ohms | <200 ohms | Similar<br>Although subject<br>device has<br>slightly higher<br>impedance, it is<br>still <2kohm and<br>should not affect<br>safety and<br>effectiveness of<br>subject device |
| Force required to<br>remove wire from<br>electrode | More than 6 pounds of<br>force | More than 6 pounds of<br>force | Same |
| OTC or<br>Prescription | OTC and Prescription | OTC and Prescription | Same |
| Single Patient Use | Single Patient Use | Single Patient Use | Same |

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# Performance:

The Adhesive Electrodes are composed of conductive carbon film, and carbon film coated with silver. They are identical to GMDASZ's previous 510K cleared electrodes in K092546 This submission supports a change only to allow the product to be sold for Over-The-Counter (OTC) use. The electrodes are compared to the Wandy Rubber Industrial Co., Ltd. Self-adhesive electrodes. K132998. The mechanical and electrical properties of the submitted GMDASZ electrodes are the same as the Wandy Self-adhesive electrodes.

For Adhesive Electrodes composed of Aluminum foil film, all the materials are same as the previously cleared electrodes in K092546 except the conductive media, so no new biocompatibility tests were conducted. To verify the safety and performance of it, GMDASZ conducted new tests. These tests are the same as our previous cleared prescription electrode in K092546, including safety test, adhesion test, current dispersion test, reusability and stability test as well as some performance test by refer to EC12/EC53. The test result shows the new electrodes with aluminum foil film is identical to the both the GMDASZ and Wandy predicate devices in safety and performance characteristics.

# Clinical:

No clinical tests were needed.

# Conclusion:

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