TENS Electrodes

K160081 · Cathay Manufacturing Corp. · GXY · Oct 19, 2016 · Neurology

Device Facts

• Record ID: K160081
• Device Name: TENS Electrodes
• Applicant: Cathay Manufacturing Corp.
• Product Code: GXY · Neurology
• Decision Date: Oct 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The proposed device is intended for use as the disposable, conductive adhesive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It's for OTC use.

Device Story

TENS Electrodes function as disposable, conductive adhesive interfaces between patient skin and external electrical stimulators (TENS/EMS). Device consists of electrode pad and wire; available in various shapes (rectangular, round, butterfly). Applied by patient (OTC use) to skin; adhesive hydrogel secures device without external materials. Device conducts electrical current from stimulator to patient tissue. Benefits include facilitating TENS/EMS therapy for pain management or muscle stimulation. No active processing or electronic components; passive conductive interface.

Clinical Evidence

Bench testing only. Evaluated via electrical impedance, adhesive performance, tensile strength, conformability, impedance distribution uniformity, biocompatibility (ISO 10993), stability, and reuse testing. Safety of lead wires/cables verified per IEC 60601-1 and IEC 60601-2-10.

Technological Characteristics

Non-sterile, flexible laminated structure. Materials: non-woven fabric, adhesive, PVC-coated wire/terminal, hydrogel, PET fabric, carbon fiber, reinforcing fiber, poly-isobutylene, carbon black, silicon-coated PET liner. Passive conductive interface. Dimensions vary by model. Conforms to IEC 60601-1 and IEC 60601-2-10.

Indications for Use

Indicated for use as a disposable, conductive adhesive interface between patient skin and electrical stimulators (TENS/EMS) for OTC application of electrical stimulation current. No specific patient population, age, or gender restrictions.

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

• SELF-ADHESIVE ELECTRODES (K080276)

Reference Devices

• Top-Rank Adhesive Electrodes (K132588)

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 consists of a stylized eagle or bird-like figure with three overlapping profiles facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure.

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

October 19, 2016

Cathay Manufacturing Corp. % Mr. Fan, Tao Consultant Shanghai YunTao Management Consultant Room 202, No. 14, Lane 986, Gaosi Road Pudong District Shanghai, 201203 China

Re: K160081

Trade/Device Name: TENS Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: September 3, 2016 Received: September 19, 2016

Dear Mr. Fan. Tao:

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

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Part 807): labeling (21 CFR Part 801 and Part 809): 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 801and Part 809), 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リ. Hoffmann -A

Carlos L. Peña, PhD, MS for 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) K160081

Device Name TENS Electrodes

Indications for Use (Describe)

The proposed device is intended for use as the disposable, conductive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It's for OTC use.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510(k) Summary

| Submitter: | CATHAY MANUFACTURING CORP.<br>No. 328, Xishe Road, Maogang Town, Songjiang Area<br>Shanghai, CN 201607 |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Fan, Tao<br>Phone: [phone]<br>Fax: [phone]<br>[e-mail] |
| Date Prepared: | Oct. 18, 2016 |
| Device Trade Name: | TENS Electrodes |
| Device Common Name: | Neurostimulation Electrodes |
| Classification name: | Cutaneous Electrodes |
| Class: | II |
| Regulation: | 882.1320 |
| Product Code: | GXY |

# Primary Predicate Device:

| Device | Company | Product Code | 510(k) Number |
|-----------------------------|---------------------------------------------------|--------------|---------------|
| SELF-ADHESIVE<br>ELECTRODES | CATHAY Healthcare<br>Equipment Manufacturing Inc. | GXY | K080276 |

# A Reference Device Chosen:

| Top-Rank Adhesive | Top-Rank Health Care Co., | GXY | K132588 |
|-------------------|---------------------------|-----|---------|
| Electrodes | Ltd | | |

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#### 1. Indication for Use:

The proposed device is intended for use as the disposable, conductive adhesive interface between the patient's skin and the electrical stimulator to apply electrical stimulation current, and is intended to be used with marketed electrical stimulators. i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).

It's for OTC use.

## 2. Product Description:

The proposed TENS Electrodes are non-sterile laminated, flexible structures composed of materials commonly used in this application:

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

The proposed device mainly consists of electrode pad and wire. The electrode pad is available in rectangular shape, round shape, and butterfly shape, etc.

| Shape | Product Model | Shape | Product Model |
|--------------|-------------------------|--------------|-----------------------|
| Image: Shape | ☐ CM2040FC ☐ CM5570FC | Image: Shape | ☐ CM2222FC ☐ CM6060FC |
| | ☐ CM3050FC ☐ CM5575FC | | ☐ CM3232FC ☐ CM6565FC |
| | ☐ CM3060FC ☐ CM5590FC | | ☐ CM4040FC ☐ CM7070FC |
| | ☐ CM4050FC ☐ CM6070FC | | ☐ CM4545FC ☐ CM7575FC |
| | ☐ CM4060FC ☐ CM6080FC | | ☐ CM4848FC ☐ CM8080FC |
| | ☐ CM4070FC ☐ CM6090FC | | ☐ CM5050FC ☐ CM8585FC |
| | ☐ CM4080FC ☐ CM60100FC | | ☐ CM5555FC ☐ CM9090RC |
| | ☐ CM4090FC ☐ CM7080FC | Image: Shape | ☐ CM22RC ☐ CM60RC |
| | ☐ CM40100FC ☐ CM70100FC | | ☐ CM25RC ☐ CM65RC |
| | ☐ CM4580FC ☐ CM70120FC | | ☐ CM32RC ☐ CM70RC |
| | ☐ CM4590FC ☐ CM75125FC | | ☐ CM40RC ☐ CM75RC |
| | ☐ CM45100FC ☐ CM80100FC | | ☐ CM45RC ☐ CM85RC |
| | ☐ CM5060FC ☐ CM80110FC | | ☐ CM50RC ☐ CM90RC |
| | ☐ CM5070FC ☐ CM80120FC | Image: Shape | ☐ CM55RC |
| | ☐ CM5090FC ☐ CM80130FC | | ☐ CM4050TC ☐ CM5580SC |
| | ☐ CM50100FC ☐ CM90120FC | Image: Shape | ☐ CM4560TC ☐ CM7090TC |
| | ☐ CM50130FC ☐ CM90130FC | | ☐ CM4570SC |
| | ☐ CM5565FC ☐ CM100180FC | | ☐ CM2542YC |
| | | | |

wire: _ 0 2. Omn Packaging : 22PCS 04PCS 6PCS 88PCS

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| ELEMENT<br>OF<br>COMPARISON | SUBJECT DEVICE | Primary Predicate Device | A Reference Device chosen | |
|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | K080276 | K132588 | |
| | | SELF-ADHESIVE<br>ELECTRODES | Top-Rank Adhesive Electrodes | |
| Indications for<br>Use | The proposed device is<br>intended for use as the<br>disposable, conductive<br>adhesive interface between<br>the patient's skin and the<br>electrical stimulator to apply<br>electrical stimulation<br>current, and is intended to<br>be used with marketed<br>electrical stimulators, i.e.<br>TENS (Transcutaneous<br>Electrical Nerve<br>Stimulation) and EMS<br>(Electrical Muscular<br>Stimulation).<br>It's for OTC use | The electrotherapy<br>electrodes are<br>intended to be used to<br>apply electrical<br>stimulation current to<br>the patient's skin or<br>record physiological<br>signals | Adhesive electrodes are<br>intended for use as the<br>disposable, conductive<br>adhesive interface between<br>the patient's skin and the<br>electrical stimulator. Top-Rank<br>Adhesive Electrodes are<br>intended to be used with<br>marketed Electrical<br>Stimulators, i.e. TENS<br>(Transcutaneous Electrical<br>Nerve Stimulation) and<br>EMS(Electrical Muscular<br>Stimulation). It's for OTC use. | |
| OTC or<br>Prescription | For OTC Use | For Prescription use | For OTC use | |
| Sterility | Non-sterile | Non-sterile | Non-sterile | |
| Design Features | Substrate / Wire/ Hydro-Gel | Substrate / Wire/ Hydro-Gel | Substrate /Wire/Hydro-Gel | |
| | Scrim / Conductive Fiber | Scrim / Conductive Fiber | Scrim/Conductive Fiber | |
| | Carbon Conductive Film / Liner | Carbon Conductive Film / Liner | Carbon Conductive Film / Liner | |
| Materials:<br>Substrate;<br>Wire:<br>Hydro-gel;<br>Scrim;<br>Conductive<br>fiber;<br>Carbon<br>conductive<br>film;<br>Liner | Non-woven fabric+ adhesive | Non-woven fabric+ adhesive | Non-woven fabric+ adhesive | |
| | Wire & Terminal coated PVC | Wire & Terminal coated PVC | Wire & Terminal coated PVC | |
| | Hydro-gel | Hydro-gel | Hydro-gel | |
| | PET fabric | PET fabric | PET fabric | |
| | Carbon fiber + reinforcing<br>fiber | Carbon fiber + reinforcing fiber | Carbon fiber + reinforcing fiber | |
| | Poly-isobutylene, Carbon<br>Black | Poly-isobutylene, Carbon Black | Poly-isobutylene, Carbon Black | |
| | Transparent PET liner<br>coated silicon | Transparent PET liner coated<br>silicon | Transparent PET liner coated silicon | |
| Biocompatibility | Conforms to<br>ISO10993 | Conforms to<br>ISO10993 | Conforms to<br>ISO10993 | |
| Labeling | confirm to 21 CFR Part 801 | confirm to 21 CFR Part 801 | confirm to 21 CFR Part 801 | |
| Performance | Conforms to IEC 60601-1<br>and<br>IEC 60601-2-10:2012,<br>Part 2 Particular<br>requirements for the basic<br>safety and essential<br>performance of nerve and<br>muscle stimulators. | Conforms to IEC 60601-1<br>and<br>IEC 60601-2-10:2012,<br>Part 2 Particular<br>requirements for the basic<br>safety and essential<br>performance of nerve and<br>muscle stimulators. | Conforms to IEC 60601-1<br>and<br>IEC 60601-2-10:2012,<br>Part 2 Particular requirements for the<br>basic safety and essential<br>performance of nerve and muscle<br>stimulators. | |
| Electrical<br>impedance | Individual pad impedance<br>below 200 ohms @ 60<br>kHz | By linking the connector to<br>gel using a multi-meter. Set<br>the range at x1k ohm.<br>Pass if the needle of multi-<br>meter moves | By linking the connector to gel using<br>a multi-meter. Set the range at x1k<br>ohm.<br>Pass if the needle of multi-meter<br>moves | |
| | ELEMENT<br>OF<br>COMPARISON | SUBJECT DEVICE | Primary Predicate Device | A Reference Device chosen |
| | | | K080276 | K132588 |
| | | | SELF-ADHESIVE<br>ELECTRODES | Top-Rank Adhesive Electrodes |
| | Electrode types,<br>shapes, and<br>sizes used for<br>testing | Largest model:<br>CM100180FC (Rectangle<br>shape: 100 x 180 mm);<br>Smallest model:<br>CM2222FC(square<br>shape: 22 x 22 mm);<br>Irregular representative:<br>CM2542YC(crescent ) | Largest and irregular model:<br>CM100200 (butterfly shape:<br>100 x 200 mm)<br>Smallest model:<br>CM2222 (Square shape: 22<br>x 22 mm) | A most common used sample:<br>AF5050WP(Square Shape: 50 x50<br>mm) |
| To | Adhesive<br>performance on | >= No.14 steel ball<br>(Diameter: 11.112 mm)<br>following AS07-003 /<br>GB/T4852-2002 | >= No.14 steel ball<br>(Diameter: 11.112 mm)<br>following AS07-003 /<br>GB/T4852-2002 | >= No.14 steel ball (Diameter:<br>11.112 mm) following AS07-003 /<br>GB/T4852-2002 |
| | Adhesive<br>holding strength<br>performance | A sample pad with 25mm<br>length and 25 mm width;<br>Hang a weight of 200g<br>without detach within 30s | A sample pad with 25mm<br>length and 25 mm width;<br>Hang a weight of 200g<br>without detach within 30s | A sample pad with 25mm length and<br>25 mm width:<br>Hang a weight of 200g without<br>detach within 30s |
| | Tensile Strength | Electrode is held up with a<br>weight of 500g hung on<br>the wire, and can hold on<br>at least 1 minutes | Electrode is held up with a<br>weight of 500g hung on the<br>wire, and can hold on at least<br>1 minutes | Electrode is held up with a weight of<br>500g hung on the wire, and can hold<br>on at least 1 minutes |
| Test | Conformability | No more than 10% of the<br>adhesive area of the<br>device shall have<br>separated from the skin<br>surface at 1 h after<br>application. | No more than 10% of the<br>adhesive area of the device<br>shall have separated from<br>the skin surface at 1 h after<br>application. | No more than 10% of the adhesive<br>area of the device shall have<br>separated from the skin surface at 1<br>h after application. |
| | Impedance<br>Distribution<br>uniformity test | 1) No significant deviation<br>between resistance<br>values measured for each<br>combination mode.<br>2) The maximum value<br>and the minimum value<br>should be within ±10% of<br>average value | 1) No significant deviation<br>between resistance values<br>measured for each<br>combination mode.<br>2) The maximum value and<br>the minimum value should be<br>within ±10% of average<br>value | 1) No significant deviation between<br>resistance values measured for each<br>combination mode.<br>2) The maximum value and the<br>minimum value should be within<br>±10% of average value |
| | Stability and<br>shelf life | 2 year | 2 year | 2 year |
| | Re-usable | For single patient | For single patient | For single patient |
| | Intended<br>population | No specified population | No specified population | No specified population |

# 4. Summary of Technology Characteristics and Performance Testing (Comparison to the Primary Predicate Device and Reference Device)

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| Comparison<br>Summary | Compare to primary predicate device specified in K080276, our device and the<br>predicate device are same in Essential Components, raw materials, physical<br>features, and same manufacturing processes. One difference is that our proposed<br>device does not claim for recording physiological signals as the predicate device<br>does. Another difference is predicate device is intended for prescription use, and our<br>proposed product is for Over-the-Counter (OTC) use.<br>Our product and the predicate device are the same in intended for use, essential<br>components, physical and general safety features based on ISO international<br>standards. The hydro-gel used in K080276 is not different from what is used in<br>CATHAY TENS Electrodes.<br>Compare to both primary predicate device and reference device, the proposed<br>device has different test method for electrical impedance. However, this test method<br>is a more sensitive & improved test method. Previously, proposed device test<br>method for electrical impedance was exactly the same as predicate device and<br>reference device, and all tests can pass previous test method also. |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Compare to the primary predicate device and reference device, the subject device<br>is constructed in the same manner,<br>is constructed of same or similar materials,<br>have same or similar indications for use, and<br>have similar performance characteristics<br>Any minor visual, dimensional or labeling differences between the primary<br>predicate device and reference device and the proposed electrodes do not pose risk<br>to their performance and usage. |

## 5. Bench Testing (non-clinical):

Compare to primary predicate product specified in K080276, our device and the predicate device are same in Essential Components, raw materials, physical features, and same manufacturing processes. The biocompatibility performance equivalence evidence of proposed electrode can be demonstrated.

The proposed TENS Electrodes evaluated through Electrode Performance testing (Electrical Impedance Performance, Adhesive Performance, and Tensile Strenght), Biocompatibility testing, Stability testing, and Reuse testing.

The comparison tests conclusively prove that the proposed electrode is similar / equivalence as performance efficient at electrical impedance, adhesive performances, tensile strength, conformability, and impedance distribution uniformity performance as the primary predicate device and reference device.

For lead wires & cables used in proposed device, the safety performances are demonstrated by the Third party, TUV Rheiland, through testing following IEC

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60601-1:2005+CORR. 1(2006) + CORR.2(2007) + AM1(2012), Part 1General requirements for basic safety and essential performance, and IEC 60601-2-10:2012, Part 2 Particular requirements for the basic safety and essential performance of nerve and muscle stimulators.

The results of bench testing & type testing provide reasonable assurance that the proposed device has been designed and validated to assure conformance to the requirements for its indication for use.

## 6. Conclusion:

Based on the indication for use, technology characteristics, and performance testing, the proposed product, TENS Electrodes, has been shown to be appropriate for its indication for use and is considered to be substantially equivalent to the primary predicate device and reference device.