Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a passive electrode device and explicitly states "Mentions AI, DNN, or ML: Not Found".

Therapeutic

No.
The device is a TENS electrode, which acts as a disposable interface to apply electrical stimulation current; it does not directly provide the therapeutic stimulation.

Diagnostic

No

The device is an interface for applying electrical stimulation current from an electrical stimulator (TENS/EMS) to the patient's skin. It is used for therapeutic purposes, not for diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a physical product composed of "electrode pad and wire" and is a "disposable, conductive adhesive interface." It undergoes testing related to physical properties like electrical impedance, adhesive performance, and tensile strength, which are characteristic of hardware components, not software.

IVD (In Vitro Diagnostic)

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

Here's why:

Intended Use: The intended use is to provide a conductive interface between the patient's skin and an electrical stimulator (TENS/EMS) to apply electrical stimulation current. This is a therapeutic or physical intervention, not a diagnostic test performed in vitro (outside the body).
Device Description: The device is described as a disposable, conductive adhesive interface for applying electrical stimulation. This aligns with a device used for physical therapy or pain management, not for analyzing biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a disease or condition.

Therefore, this device falls under the category of a medical device used for electrical stimulation, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

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

GXY

Device 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's skin

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The proposed TENS Electrodes were evaluated through Electrode Performance testing (Electrical Impedance Performance, Adhesive Performance, and Tensile Strength), 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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Electrical impedance: Individual pad impedance below 200 ohms @ 60 kHz
Adhesive performance on Adhesive holding strength performance: >= No.14 steel ball (Diameter: 11.112 mm) following AS07-003 / GB/T4852-2002
Tensile Strength: A sample pad with 25mm length and 25 mm width; Hang a weight of 200g without detach within 30s
Test: Electrode is held up with a weight of 500g hung on the wire, and can hold on at least 1 minutes
Conformability: No more than 10% of the adhesive area of the device shall have separated from the skin surface at 1 h after application.
Impedance Distribution uniformity test: 1) No significant deviation between resistance values measured for each combination mode. 2) The maximum value and the minimum value should be within +/-10% of average value
Stability and shelf life: 2 year

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K080276

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K132588

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

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

Summary

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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

1

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

2

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.
No. 328, Xishe Road, Maogang Town, Songjiang Area
Shanghai, CN 201607 |
|----------------------|--------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Fan, Tao
Phone: (86)18616806984
Fax: (86)-21-57876338
fant01@uwellmed.com |
| 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
SELF-ADHESIVE
ELECTRODES	CATHAY Healthcare
Equipment Manufacturing Inc.	GXY	K080276

A Reference Device Chosen:

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

4

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

5

| ELEMENT
OF

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

The maximum value
and the minimum value
should be within ±10% of
average value | 1) No significant deviation
between resistance values
measured for each
combination mode.
The maximum value and
the minimum value should be
within ±10% of average
value | 1) No significant deviation between
resistance values measured for each
combination mode.
The maximum value and the
minimum value should be within
±10% of average value |
| | Stability and
shelf life | 2 year | 2 year | 2 year |
| | Re-usable | For single patient | For single patient | For single patient |
| | Intended
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)

6

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

8

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.