Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes simple cutaneous electrodes for TENS devices and does not mention any AI or ML capabilities.

Therapeutic

No.
The device is described as "cutaneous electrodes to be used with legally marketed TENS stimulating devices," indicating it is an accessory to a therapeutic device rather than a therapeutic device itself.

Diagnostic

No

Explanation: The device description states that these are "cutaneous electrodes" designed to "deliver the stimulation signals generated by" TENS devices. This indicates their function is for therapeutic electrical stimulation, not for diagnosis. There is no mention of measuring or analyzing biological signals for diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description clearly describes physical electrodes made of silver-coated Nylon yarn or conductive silicone rubber, which are hardware components. The performance studies also focus on testing the physical properties and biocompatibility of these electrodes.

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 clearly states that the electrodes are for use with TENS stimulating devices to deliver electrical stimulation to the skin. This is a therapeutic application, not a diagnostic one.
Device Description: The description focuses on the physical properties of the electrodes and their conductivity, which are relevant to delivering electrical signals, not 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 patient's health status.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

XinBo Electrodes (Model: Neck Therapy Pro - II; Neck Therapy Pro - II; Neck Therapy Pro - III, Neck Therapy Pro - IV) are cutaneous electrodes to be used with legally marketed TENS stimulating devices for which stimulation of the back of the neck and upper back is appropriate. They will deliver the stimulation signals generated by the back of the neck, upper back and shoulder surface areas with which they are in contact.

Product codes

GXY

Device Description

The electrodes can be use together with any legally marketed TENS stimulating devices for which stimulation of the back of the neck and upper back is appropriate. For the silver coated Nylon yarn electrodes, they can be used dry or wet when in contact with the skin. The entire surface of each electrodes is very conductive having a resistance of less than 7 ohms per inch; For the model "Neck Therapy Pro - III", conductive silicone rubber having a resistance of less than 7 ohms per inch, these low resistance provides low current density with uniform current distribution.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

back of the neck, upper back and shoulder surface areas

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Over-The-Counter Use

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)

XinBo Electrodes have been evaluated the safety and performance by lab bench testing as following:

Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
The electrode wire is compliance with 21 CFR 898 by IEC 60601-1 (version 3.1, clause 8.5.2.3) evaluation.
Performance test (hot spots verification test) according to manufacturer self-requirements.
Usability study according to IEC 60601-1-6, IEC 62366, and "FDA Guidance for Applying Human Factors and Usability Enqineering to Medical Devices"

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

Not Found

Predicate Device(s)

K053214, K151693, K121483

Reference Device(s)

Not Found

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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 19, 2018

Guangzhou Xinbo Electronic Co., Ltd. % Ms. Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, Guandong, 510006 Cn

Re: K172887

Trade/Device Name: XinBo Electrode (Model: Neck Therapy Pro - I. Neck Therapy Pro - II. Neck Therapy Pro - III, Neck Therapy Pro - IV) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: January 14, 2018 Received: January 19, 2018

Dear Ms. Cassie Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good 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.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Vivek J. Pinto -S

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) K172887

Device Name XinBo Electrodes

Indications for Use (Describe)

XinBo Electrodes (Model: Neck Therapy Pro - II; Neck Therapy Pro - II; Neck Therapy Pro - III, Neck Therapy Pro - IV) are cutaneous electrodes to be used with legally marketed TENS stimulating devices for which stimulation of the back of the neck and upper back is appropriate. They will deliver the stimulation signals generated by the back of the neck, upper back and shoulder surface areas with which they are in contact.

Type of Use (Select one or both, as applicable)
	Indoor Use (Applicable to OFF!® Insect Repellents Only)
	Outdoor Use (Applicable to OFF!® Insect Repellents Only)

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

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3

510(k) Summary

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

510(k) Owner's Name: Guangzhou Xinbo Electronic Co., Ltd. Establishment Registration Number: K172887 Address: 2nd Building, Juntuo Industry Park, XinqyeDadao, Nancun Town, Panyu District, Guangzhou City, Guangdong Province, China Contact Person: Li Huifang (Manager) Email: drtvsammy@hotmail.com

Application Correspondent:

Contact Person: Ms. Cecilia Ceng / Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: Suite 306, Kecheng Mansion, No.121 Science Road, Guangzhou Science Park, Guangzhou 510663, China Tel: +86-20-61099984 Email: regulatory@glomed-info.com

2. Subject Device Information

Trade Name: XinBo Electrodes Common Name: Cutaneous Electrode Review Panel: Neurology Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV Regulation Number: 882.1320

3. Predicate Device Information

Sponsor	Neurotron Medical, Inc	DRTV Asia Ltd.	AMPCAXE, LLC
Device Name	Theraknit Garments	Dr-Ho's Foot Pad
Electrode	AMPCARE 50709
Series Electrodes
510(k) Number	K053214	K151693	K121483
Product Code	GXY	GXY	GXY
Regulation
Number	882.1320	882.1320	882.1320
Regulation Class	II	II	II

4. Device Description

The electrodes can be use together with any legally marketed TENS stimulating devices for which stimulation of the back of the neck and upper back is appropriate. For the silver coated Nylon yarn electrodes, they can be used dry or wet when in contact with the skin. The entire surface of each

4

electrodes is very conductive having a resistance of less than 7 ohms per inch; For the model "Neck Therapy Pro - III", conductive silicone rubber having a resistance of less than 7 ohms per inch, these low resistance provides low current density with uniform current distribution.

5. Intended Use / Indications for Use

XinBo Electrodes (Models: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) are cutaneous electrodes to be used with legally marketed TENS stimulating devices for which stimulation of the back of the neck and upper back is appropriate. They will deliver the stimulation signals generated by the stimulator to the back of the neck, upper back and shoulder surface areas with which they are in contact.

6. Test Summary

XinBo Electrodes have been evaluated the safety and performance by lab bench testing as following:

Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards �
The electrode wire is compliance with 21 CFR 898 by IEC 60601-1 (version 3.1, clause 8.5.2.3) � evaluation.
� Performance test (hot spots verification test) according to manufacturer self-requirements.
� Usability study according to IEC 60601-1-6, IEC 62366, and "FDA Guidance for Applying Human Factors and Usability Enqineering to Medical Devices"

7. Comparison to predicate device and conclusion

The technological characteristics, features, specifications, materials, and intended use of subject device are substantially equivalent to the predicate devices.

The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.

| Elements of

Comparison	Subject Device	Predicate Device 1	Predicate Device 2	Predicate Device 3	Remark
Device Name
and Model	XinBo Electrodes
(Models: Neck
Therapy Pro - I, Neck
Therapy Pro - II, Neck
Therapy Pro - III, Neck
Therapy Pro - IV)	Theraknit Garments	Dr-Ho's Foot Pad
Electrode	AMPCARE 50709
Series Electrodes	--
510(k) Number	K172887	K053214	K151693	K121483	--
Product Code	GXY	GXY	GXY	GXY	SE
OTC or Rx-
only	OTC	Rx-only	OTC	Rx-only	SE
Intended Use /
Indications for
Use	XinBo Electrodes
(Models: Neck
Therapy Pro - I, Neck
Therapy Pro - II, Neck
Therapy Pro - III, Neck
Therapy Pro - IV) are
cutaneous electrodes	The TheraKnit
Garment Electrodes
are cutaneous
electrodes to be used
with legally marketed
TENS stimulating
device. The knitted	The Cutaneous
Electrodes, "Dr-Ho's
Foot Pad Electrodes",
are intended to be
used with legally
marketed electrical
stimulating devices	AMPCA RE 50709
Series of cutaneous
electrodes are
intended to be used to
apply electrical
stimulation current to
the patient's skin.	SE
to be used with legally
marketed TENS
stimulating devices for
which stimulation of
the back of the neck
and upper back is
appropriate. They will
deliver the stimulation
signals generated by
the stimulator to the
back of the neck,
upper back and
shoulder surface
areas with which they
are in contact.	garment electrodes
will deliver the
stimulation signals
generated by the
stimulator to the body
surface with which
they are in contact.
These body parts can
include hand (glove),
feet (socks), elbow or
knee (sleeve), arm,
leg, shoulder, back
(pads).	such as
transcutaneous
electrical nerve
stimulators or
powered muscle
stimulators. The
cutaneous electrodes
will deliver the
stimulation signals
generated by the
stimulator to the
bottom of the feet
which they are in
contact with.	Example electrical
stimulation current
applications of these
electrodes are:
a) Transcutaneous
Electrical Nerve
Stimulation (TENS)
for pain relief
b) Electrical muscle
stimulation (EMS) for
neck muscle
stimulation.
c) Functional
electrical stimulation
(FES)
d) Galvanic
stimulation
e) Microcurrent
electrical nerve
stimulation (MENS)
J) Interferential (IF)
stimulation
g) Neuromuscular
electrical stimulation
(NMES), including for
muscle re-education
by application of
external stimulation to
the muscles
necessary for
pharyngeal
contraction.
Body Parts to
Use on	Back of the neck,
upper back and
shoulder	Hand, feet, elbow or
knee, arm, leg,
shoulder, back	Bottom of the feet	Back of the neck	SE
Design
(Shape)	Model A: Neck
Therapy Pro - I
Model B: Neck
Therapy Pro - II
Model C: Neck
Therapy Pro - III
Model D: Neck
Therapy Pro - IV	Electrode A: Glove
Style
Electrode B: Socks
Style
Electrode C: Sleeve
Style
Electrode D: Pads
Style	Electrode A: foot-shaped Electrode		SE
Note 1
Dimensions	Model A:
For the whole product:
260 x 297.8 mm
For only the electronic
pads part: 4
electrodes on each
models, two of them
are: 65 mm in
diameter, the other
two of them are
irregularly: 75 mm in
diameter and about
105 mm long
Model B:
For the whole product:				SE
Note 1

	208 x115 x110 mm
For only the electronic
pads part: 2
electrodes on each
models, each
electrode is: 50 mm in
diameter
Model C:
For the whole product:
264.2 x 298.5 mm
For each the
electronic pads part: 6
electrodes on each
models, each
electrode is: 48 x26.2
mm²
Model D:
For the whole product:
300x 450 x 110mm
For each electronic
pads part: 4
electrodes on each
models, each
electrode is: 45 mm in
diameter
Impedance	For Model A: 7 ohms	7 ohms resistance per inch