(90 days)
Not Found
No
The device description and performance studies indicate a passive electrical conductor without any mention of AI or ML capabilities.
No
This device is a self-adhesive electrode, which functions as a passive interface to carry electrical signals from other stimulation devices (e.g., TENS, EMS) to the patient's skin. It is not the therapeutic device itself, but rather an accessory to such devices.
No
The device is described as a "Self-adhesive electrode" that functions as a "passive device by carrying an electrical signal from a stimulation device ... to the user skin." Its intended use is with "electrical stimulation devices" like TENS and EMS, which are therapeutic, not diagnostic. There are no mentions of it being used to detect or analyze medical conditions.
No
The device description explicitly states it is composed of physical components like non-woven fabric, adhesive tape, conducting film, hydrogel, and plastic film, and functions as a passive device carrying an electrical signal. This indicates a hardware-based medical device, not software-only.
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 electrical stimulation devices (like TENS and EMS). This is a therapeutic or physical therapy application, not a diagnostic one.
- Device Description: The description details the physical components and how it functions as a passive conductor of electrical signals. It does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.), which is the core function of an IVD.
- Performance Studies: The performance studies focus on electrical properties, adhesion, and biocompatibility – all relevant to a device that interacts with the skin and conducts electricity for therapeutic purposes. There are no studies related to diagnostic accuracy or the analysis of biological markers.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This self-adhesive electrode does not perform any such function.
N/A
Intended Use / Indications for Use
Self-adhesive electrode is intended for single use, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use, for single patient use only.
Product codes
GXY
Device Description
The self-adhesive electrode is available in two models: lead wire type and snap type. Both models are composed of a non-woven fabric, a double side adhesive tape, conducting film, hydrogel, and plastic film. The construction difference between the two types is the electrical connection component, which is either a lead wire or a snap.
The non-woven lead wire type electrode is available in rectangular and circular shapes with various sizes. The non-woven snap type electrode is available in rectangular, circular, oval, and hand shapes, also in various sizes.
The device functions as a passive device, carrying an electrical signal from a stimulation device through its cable and electrode lead wire or snap to the user's skin. The electrical signal is dispersed across the conductive film and then transmitted through the conductive adhesive hydrogel to the patient's skin surface. Key physical and performance characteristics include: electrical impedance less than 3KΩ, current deviation index less than 5%, and a 30 minutes maximum duration of use.
Materials of construction include: 100% polypropylene for the non-woven fabric, carbon paste for the conducting film, crosslinked acrylic resin, polyhydric alcohol, electrolytic salt, additives and de-ionized water for the hydrogel, PVC for the lead wire, and nickel-clad copper for the snap.
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)
Nonclinical Tests:
The self-adhesive electrode underwent performance tests for size, electrical impedance, current uniformity, and adhesion. The adhesion test was performed according to IEC 60601-2-2:2009 Clause 201.15.101.7.
It also passed three biocompatibility tests: cytotoxicity, skin irritation, and skin sensitization, performed according to ISO 10993-1, 5, and 10.
The shelf life was verified according to ASTM F 1980-07.
Clinical Tests:
Not applicable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Electrical impedance: less than 3KΩ.
- Current uniformity: the current deviation index of the electrode is less than 5%.
- Adhesive performance: 30 minutes maximum duration use.
- pH of hydrogel: 6.5~7.5
- Conductivity of hydrogel: 50 S/m
- Resistivity of hydrogel: 0.02 Ωm
- Volume of hydrogel: ranging from 0.7 to 11.7 cm³ (varies by electrode shape)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
August 7, 2018
Dong Guan Ou Kang Electronics CO., LTD % Field Fu Consultant Shenzhen Joyantech Consulting Co., Ltd. Room 1122, International Mayors Communication Centre Shenzhen, 511470 Cn
Re: K181234
Trade/Device Name: Self-adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: May 9, 2018 Received: May 9, 2018
Dear Field Fu:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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).
for
Sincerely, Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS 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) K181234
Device Name Self-adhesive electrode
Indications for Use (Describe)
Self-adhesive electrode is intended for single use, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use, for single patient use only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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
Date of summary prepared: 08/06/2018 This summary of 510(K) safety and effectiveness information is submitted as required by requirements of SMDA and 21 CFR §807.92.
1. Administrative Information
| Date of summary prepared | |
|---|---|
| Manufacturer information | Company title: Dong Guan Ou Kang Electronics CO.,LTD |
| Company address: 3rd floor, Xiqunli building, Shipai | |
| road, Yanwo village, Shipai town, Dongguan | |
| Phone: +86-0769-82686009 | |
| Fax: +86-0769-82686009 | |
| Contact person: Nianjun Liu | |
| E-mail: nianjun_liu@sohu.com | |
| Submission Correspondent | |
| Name: Shenzhen Joyantech Consulting Co., Ltd | |
| Address: Room 1122, International Mayors | |
| Communication Centre, NO. 55 Shizhou middle road , | |
| Nanshan District, Shenzhen | |
| Contact person: Field Fu; Summer Wu; Elly Xv | |
| E-mail: summer@cefda.com; elly@cefda.com |
2. Device information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade name: | Self-adhesive electrode |
| Model: | Lead wire type electrode and snap type electrode |
| Classification Name: | Electrode, Cutaneous |
| Review panel: | Neurology |
| Product Code: | GXY |
| Device Class | II |
| Regulation number: | 882.1320 |
3. Predicate Device Information
| Sponsor: | Shenzhen Mailuokang Technology Co., Ltd. |
|---|---|
| Device: | Mailuokang Self-adhesive Electrode |
| 510(k) number: | K152815 |
4
4. Device description
1) Intended use/indications for use
Self-adhesive electrode is intended for single use, conductive adhesive interface between the patient's skin and the electrical stimulation devices. Some common types of the stimulation devices include, but are not limit to, TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The electrode is for OTC (Over-The -Counter) or Prescription use, for single patient use only.
2) Device specification
The specification of self-adhesive electrode is listed below.
| Model | Shape | Product Size(mm) | Connector
Size (hole
diameter)
(mm) |
|---------------------------------------------|------------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------|
| Non-woven
lead wire
type
electrode | Rectangular
and circular | Rectangular:
40×40;40×60;50×50;50×60;50×70;50×90;50×100;60×80;60×90;70×110;90×130 | 2.0, 2.5 |
| | | | |
| | | | |
| | | | |
| | | | |
| | | Circular:
$Ф$ 30; $Ф$ 40; $Ф$ 50; $Ф$ 80 | |
| | | | |
| Non-woven
snap type
electrode | Rectangular
, circular,
oval and
hand shape | Rectangular:
40×40; 40×80; 50×50; 50×90; 50×100; 60×90 | 3.3, 3.6 |
| | | Circular:
$Ф$ 30; $Ф$ 40; $Ф$ 50; $Ф$ 80 | |
| | | | |
| | | Oval:
43×30 | |
| | | | |
| | | Hand shape:
75×46 | |
3) Device design
Non-woven lead wire type electrode and non-woven snap type electrode have different appearance and construction. See Figure 1 and Figure 2 for the structure picture of non-woven lead wire type electrode and non-woven snap type electrode.
Image /page/4/Figure/10 description: The image shows a diagram of a layered structure with labels indicating the different components. The layers, from top to bottom, are: 1 Non-woven fabric, 2 Double sides adhesive tape, 3 Conducting film, 4 Hydrogel, and 5 Plastic film. A wire labeled as 6 Carbon fiber wire is connected to the side of the layered structure.
Image /page/4/Figure/11 description: The image shows the text "Figure 1 The structure of non-woven lead wire type electrode". The text appears to be a figure caption. The caption describes the structure of a non-woven lead wire type electrode and is labeled as Figure 1.
5
Proposed product: Self-adhesive electrode
Image /page/5/Figure/3 description: The image shows a diagram of a layered structure, with labels indicating the different components. The layers, from top to bottom, are: 1 Non-woven fabric, 2 Double sides adhesive tape, 3 Conducting film, 4 Hydrogel, and 5 Plastic film. There is also a component labeled 6 Snap on the top layer.
Figure 2 The structure of non-woven snap type electrode
4) Materials used
Both non-woven lead wire type electrode and snap type electrode are composed of a non-woven fabric, a double side adhesive tape, conducting film, hydrogel and plastic film. The construction difference between non-woven lead wire electrode and non-woven snap electrode is lead wire and snap.
5) Physical and performance characteristics of the device
Electrical impedance: less than 3KΩ.
Current uniformity: the current deviation index of the electrode is less than 5%. Adhesive performance: 30 minutes maximum duration use.
6) Principle of Operation
Self-adhesive electrode functions as a passive device by carrying an electrical signal from a stimulation device through the device cable and electrode lead wire or snap to the user skin. Electrical signal from an electrical stimulator is conducted to the self-adhesive electrode through a lead wire or snap; which is dispersed across the conductive film, then transmitted through the conductive adhesive hydrogel to the surface of the patient's skin.
| Component | Material |
|---|---|
| Non-woven fabric | 100% polypropylene in white |
| Conducting film | Carbon paste |
| Hydrogel | Cross linked acrylic resin, polyhydric alcohol, electrolytic salt, additives and de-ionized water |
| Lead wire | PVC |
| Snap | Nickel-clad copper |
7) Material of construction
5. Technological characteristics of the subject device compared to the predicate device
| Items | Predicate
(K152815) | Device | Subject Device | Comparison |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|------------|
| General Characteristics | | | | |
| ltems | Predicate
Device
(K152815) | Subject Device | Comparison | |
| Classification
Name | Cutaneous Electrode | Cutaneous Electrode | Same. | |
| Product Code | GXY | GXY | Same. | |
| Regulation
Number | 882.1320 | 882.1320 | Same. | |
| Device Class | Class II | Class II | Same. | |
| Intended
Use/Indicatio
ns for Use | Mailuokang
Self-adhesive
Electrode is intended
for use as reusable,
conductive adhesive
interface between the
patient's skin and the
electrical stimulation
devices. Example
electrical stimulation
devices for current
applications of the
electrodes includes,
but are not limited to,
TENS
(Transcutaneous
Electrical Nerve
Stimulation) and EMS
(Electrical Muscle
Stimulation).
Mailuokang
Self-adhesive
Electrode is for
prescription use and
over-the-counter use,
for single patient use
only. | Self-adhesive
electrode is intended
for use as single
use, conductive
adhesive interface
between the
patient's skin and the
electrical stimulation
devices. Some
common types of the
stimulation devices
include, but are not
limit to, TENS
(Transcutaneous
Electrical Nerve
Stimulation) and
EMS (Electrical
Muscular
Stimulation). The
electrode is for OTC
(Over-The-Counter)
or Prescription use,
for single patient use
only. | Similar. (Note 1) | |
| Intended
User/Patient
Population | No specified
population. | No specified
population. | Same. | |
| Electrical
Connection | Lead wire or snap. | Lead wire or snap. | Same. | |
| OTC or
prescription
use | OTC use and
prescription use. | OTC use and
prescription use. | Same. | |
| Items | Predicate
Device
(K152815) | Subject Device | Comparison | |
| Reusable | Yes | No. | Similar. (Note 1) | |
| Single Patient
Use | Yes | Yes | Same. | |
| Multiple
Applications | Yes | No. | Similar. (Note 1) | |
| Sterility
Status | Non-sterile | Non-sterile | Same. | |
| Technical Characteristics | | | | |
| Electrode
dimensions(c
m) | For lead wire style
electrode:
Rectangular:
3×7;4×4;5×5;5×6;5×7;
6×9;8×12;8×13
For snap style
electrode:
Rectangular:
9×4
Circle:
Ф4; Ф5; Ф8.5
Oval:
4.5×3 | For
non-woven
lead-wire
type
electrode:
Rectangular:
4×4;4×6;5×5;5×6;5×
7;5×9;5×10;6×8;6×9;
7×11;9×13
Circular:
Ф3; Ф4; Ф5; Ф8
For non-woven snap
type electrode:
Rectangular:
4×4; 4×8; 5×5; 5×9;
5×10; 6×9
Circular:
Ф3; Ф4; Ф5; Ф8
Oval:
4.3×3
Hand shape:
7.5×4.6 | Similar. (Note 2) | |
| Conductive
surface
area(cm2) | 12.56104 | 7117 | Similar. (Note 2) | |
| Design
Features | Six basic components
for Lead Wire Style
Electrode:
• non-woven
fabrics;
• double sides
adhesive tape;
• conducting film;
• hydrogel;
• plastic film; | Six basic
components for Lead
Wire Style Electrode:
• non-woven
fabrics;
• double sides
adhesive tape;
• conducting film;
• hydrogel;
• plastic film; | Same. | |
6
Proposed product: Self-adhesive electrode
7
8
Proposed product: Self-adhesive electrode
| Items | Predicate
(K152815) | Device | Subject Device | Comparison | | | | | | | | | | | | | | | | | | |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--|--------|
| | • carbon fiber wire.
Six basic components
for Snap Style
Electrode:
• non-woven
fabrics;
• double sides
adhesive tape;
• conducting film;
• hydrogel;
• plastic film;
• snap. | | • carbon fiber wire.
Six basic
components for Snap
Style Electrode:
• non-woven
fabrics;
• double sides
adhesive tape;
• conducting film;
• hydrogel;
• plastic film;
• snap. | | | | | | | | | | | | | | | | | | | |
| Hydrogel
Composition | Glyrol, Polyacrylic
acid, Water and Salt | | Crosslinked acrylic
resin, polyhydric
alcohol, electrolytic
salt, additives and
de-iconized water. | Similar.
(Note 43) | | | | | | | | | | | | | | | | | | |
| Function and
concentration
of each
ingredient in
final
formulation | Not publicly available. | | Ingredient Concentration
(WT%) Function Crosslinked
acrylic resin 15-25 Cross-
linking
polymerization. polyhydric
alcohol 40-60 Buffer
and
humectant. electrolytic
salt 2-10 Ionic
conducting
media additives