(23 days)
The Self-adhesive Electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.
The Self-adhesive electrode, lead wire type and snap button type, are non-sterile flexible structures, composed of materials commonly used in this application:
First layer: Non-woven fabric tape
Second layer: Polyurethane (PU) electrically conductive carbon cloth (Hebei Kangshengda Electronic Technology Co., Ltd)
Third layer: Biocompatible conductive hydrogel coupling media (ValueTrode Carbon, K970426), which has passed the required skin sensitivity testing criteria as specified in ISO 10993-10 and cytotoxicity testing criteria as specified in ISO 10993-5.
The electrodes are designed for single patient / multiple application use. It can be used for low-frequency or medium-frequency nerve or muscle stimulators, as the conduction film adhered to body skin.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Self-adhesive Electrode" (K213879), structured according to your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary does not explicitly list "acceptance criteria" for each parameter in the way a formal study report might. Instead, it demonstrates substantial equivalence to a predicate device (K090198) by comparing various characteristics and reporting that the new device met specific test standards or manufacturer requirements.
The table below presents the comparative data and implies the "acceptance criteria" are generally that the new device's performance is similar to or meets the standards met by the predicate device, or adheres to established industry standards for such devices.
| Parameter | Acceptance Criteria (Implied / Indirect) | Reported Device Performance (New Device) | Remark (from document) |
|---|---|---|---|
| Formulation/Design Characteristics | |||
| Trade Name | (Not applicable for acceptance criteria) | Self-adhesive Electrode | -- |
| Common Name | Same as predicate | Cutaneous electrode | Same |
| Classification Name | Same as predicate | Electrode, cutaneous | Same |
| Product Code | Same as predicate | GXY | Same |
| Device Class | Same as predicate | II | Same |
| Regulation Number | Same as predicate | 882.1320 | Same |
| Medical Specialty | Same as predicate | Neurology | Same |
| Indications for use | Same as predicate | The Self-adhesive Electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS. | Same |
| Target population | Same as predicate (Single patient use and multiple application) | Single patient use and multiple application | Same |
| Type of use | Same as predicate (OTC and Prescription use) | OTC and Prescription use | Same |
| Design (shape & connection) | Similar to predicate, customized specification allowed | Round, Rectangle, Elliptical, Calabash, Butterfly, Palm shape according to customized specification. Lead wire with female socket, or snap button with male snap connector. | Similar |
| Materials | Similar to predicate and biocompatible standards met | - Non-woven fabric tape- Polyurethane (PU) electrically conductive carbon cloth- Biocompatible conductive hydrogel coupling media (ValueTrode Carbon, K970426) | Similar |
| Electrode Pad Size | Within ranges comparable to predicate | Round Min.Ø20mm; Max.Ø85mmRectangle Min.26×26mm; Max.190×110mmElliptical Min.85×45mm;Calabash Min.90×47mm; Max.200×88mmButterfly Min.73×53mm; Max.195×95mmPalm shape 74×47mm | Similar |
| Performance Characteristics | |||
| Electrode Impedance of Electrode Pad | Within ranges comparable to predicate | Round: 302 | Similar |
| Patient contact area of electrode | Within ranges comparable to predicate | Round Min.3.14cm²; Max.56.716cm²Rectangle Min.6.76cm²; Max.209cm²Elliptical Min.38.25cm²; Max.240cm²Calabash Min.42.3cm²; Max.176cm²Butterfly Min.38.69cm²; Max.185.25cm²Palm shape 34.78cm² | Similar |
| Max. current Density (IRMS=10mA calculation) | Within ranges comparable to predicate | Round: 3.18mA/cm²Rectangle: 1.48mA/cm²Elliptical: 0.52mA/cm²Calabash: 0.24mA/cm²Butterfly: 0.52mA/cm²Palm shape: 0.29mA/cm² | Similar |
| Hydrogel thickness | 35mils ± 5mils (0.89mm ± 0.13mm) | 35mils ± 5mils (0.89mm ± 0.13mm) | Same |
| Hydrogel pH | 4.2 ± 1.0 | 4.2 ± 1.0 | Same |
| Hydrogel volume resistivity | 1500 ohm-cm max | 1500 ohm-cm max | Same |
| Compliance/Safety Standards | |||
| Standards meet | Compliance with AAMI/ANSI ES 60601-1, ANSI AAMI IEC 60601-2-2, FDA's Impedance Test, ASTM F1980, and manufacturer's requirements (peeling force, simulation use) | • Lead wires test per 8.5.2.3 of AAMI/ANSI ES 60601-1;• Impedance test, Conformability test and Fluid tolerance test per 201.15.101.6 and 201.15.101.7 of ANSI AAMI IEC 60601-2-2 Edition 6.0 2017-03;• Impedance Test (Dispersion Test) according to FDA's requirement;• Peeling force test and Simulation use test according to manufacturer's requirement;• Shelf life test per ASTM F1980:2016 | Similar |
| Biocompatibility | ISO10993-5; ISO10993-10 | ISO10993-5; ISO10993-10 | Same |
| Sterility Status | Non-sterile (as per predicate) | Non-sterile | Same |
| Electrical safety | Lead wire meets Clause 8.5.2.3 of AAMI/ANSI ES60601-1 | Lead wire meets Clause 8.5.2.3 of AAMI/ANSI ES60601-1 | Same |
| Other Performance | Good electrical conductivity, good adhesive property (as per predicate) | Good electrical conductivity, good adhesive property | Same |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in terms of patient data. The evaluation relies on non-clinical bench tests performed on the "Self-adhesive Electrode" device itself.
- Sample Size: The document does not explicitly state the number of electrodes tested for each bench test. For example, it lists "Impedance test," "Conformability test," "Fluid tolerance test," "Peeling force test," and "Simulation use test" but doesn't provide the quantity of devices subjected to these tests.
- Data Provenance: The tests were "Bench tests" conducted on the proposed device. The country of origin for the device manufacturer is China (Bozhou Rongjian Medical Appliance Co.,Ltd., Anhui, China). The data is retrospective in the sense that these tests were completed before the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study did not involve human interpretation or a "ground truth" derived from expert consensus on clinical data. The tests performed were objective bench tests against established standards and comparative measurements.
4. Adjudication Method for the Test Set
This is not applicable as there was no test set involving subjective human assessment or consensus building. The assessments were based on direct measurements and compliance with technical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data was not including in this submission."
6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done
This is not applicable. The device is a self-adhesive electrode, a physical medical device, not an algorithm or software. Therefore, an "algorithm only" performance study is irrelevant. The compliance for the device involves physical and electrical characteristics.
7. The Type of Ground Truth Used
For this device, the "ground truth" or reference for performance and safety is established by:
- Established industry standards: Such as ISO 10993 series for biocompatibility, AAMI/ANSI ES 60601-1, and IEC 60601-2-2 for electrical safety and performance.
- Manufacturer's internal requirements: For tests like peeling force and simulation use.
- Predicate device characteristics: Demonstrating that the new device's properties (materials, dimensions, electrical impedance ranges) are similar to those of a legally marketed predicate device (K090198).
There is no clinical ground truth (e.g., pathology, outcomes data) as no clinical study was performed.
8. The Sample Size for the Training Set
This information is not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & 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.
January 5, 2022
Bozhou Rongjian Medical Appliance Co., Ltd. % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China
Re: K213879
Trade/Device Name: Self-adhesive Electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: November 24, 2021 Received: December 13, 2021
Dear Doris Dong:
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
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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213879
Device Name Self-adhesive Electrode
Indications for Use (Describe)
The Self-adhesive Electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS.
| 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
[As required by 21 CFR 807.92]
1. Submission Information
| 510(k) Number: | K213879 |
|---|---|
| Date: | November 24, 2021 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Manufacturer/Applicant: | Bozhou Rongjian Medical Appliance Co.,Ltd.Jianghuai Supply Base, Zhongkai Group, Mengcheng County, BozhouCity, 233500 Anhui, ChinaTel: +86-558-7963368E-mail: rongjianzl@rjmed.com.cn |
| Contactor: | Doris Dong (Consultant)Shanghai CV Technology Co., Ltd.Rm. 903, No. 19 Dongbao Rd., Songjiang Area, Shanghai, 201613 ChinaE-mail: doris.d@ceve.org.cnTel: 86 21-31261348 |
2. Device Description
| 2. Device Description | |
|---|---|
| Proprietary Name: | Self-adhesive Electrode |
| Common Name: | Cutaneous electrode |
| Classification Name: | Electrode, cutaneous |
| Product Code: | GXY |
| Device Class: | II |
| Regulation Number: | 21 CFR 882.1320 |
| Review Panel: | Neurology |
| Indications for use: | The Self-adhesive Electrode is intended to be used to transmit electrical stimulation current to the patient's skin. Example electrical stimulations for current applications of the electrodes are: TENS and EMS. |
| Device Description: | The Self-adhesive electrode, lead wire type and snap button type, are non-sterile flexible structures, composed of materials commonly used in this application:First layer: Non-woven fabric tapeSecond layer: Polyurethane (PU) electrically conductive carbon cloth (Hebei Kangshengda Electronic Technology Co., Ltd)Third layer: Biocompatible conductive hydrogel coupling media (ValueTrode Carbon, K970426), which has passed the required skin sensitivity testing criteria as specified in ISO 10993-10 and cytotoxicity testing criteria as specified in ISO 10993-5.The electrodes are designed for single patient / multiple application use. It can be used for low-frequency or medium-frequency nerve or muscle stimulators, as the conduction film adhered to body skin. |
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There are six shapes of round, rectangle, elliptical, calabash, butterfly and palm shape. For the electrical connection, Rongjian provides lead wire type and snap button type:
Lead wire assembly - at least 40mm long wire with 2mm/2.5mm diameter female socket.
Snap button assembly - with 2.5~5mm diameter male socket.
The lead wire assembly is in compliance with the requirements of FDA performance standard 21 CFR part 898 by testing under ANSI/AAMI ES60601-1, subclause 8.5.2.3.
3. Predicate Device Identification
K090198 - JIAJIAN Self-adhesive Electrode
4. Non-Clinical Test Conclusion
Bench tests were conducted on Self-adhesive Electrode to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The following tests were performed on the proposed device:
· ASTM F1980-16, Standard guide for accelerated aging of sterile barrier systems for medical devices. (Sterility)
• ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
· ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for Irritation and Skin Sensitization.
• AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And
Essential Performance (IEC 60601-1:2005, MOD).
· Impedance test, Conformability test and Fluid tolerance test per 201.15.101.6 and 201.15.101.7 of IEC 60601-2-2 Edition 6.0 2017-03.
· Impedance Test (Dispersion Test) according to FDA's requirement.
· Peeling force test and Simulation use test according to manufacturer's requirement.
5. Substantial Equivalent Based on Assessment of Clinical PerformanceData
Clinical data was not including in this submission
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| Parameters | New Device | Predicate Device | Remark | |
|---|---|---|---|---|
| 1 | 510(k) Number | To be assigned | K090198 | -- |
| 2 | 510(k) Holder | Bozhou Rongjian MedicalAppliance Co.,Ltd. | Wuxi Jiajian MedicalInstrument Co., Ltd | -- |
| 3 | Trade Name | Self-adhesive Electrode | Jiajian Self- adhesive Electrode | -- |
| 4 | Common Name | Cutaneous electrode | Cutaneous electrode | Same |
| 5 | ClassificationName | Electrode, cutaneous | Electrode, cutaneous | Same |
| 6 | Product Code | GXY | GXY | Same |
| 7 | RegulationNumber | 882.1320 | 882.1320 | Same |
| 8 | MedicalSpecialty | Neurology | Neurology | Same |
| 9 | Device Class | II | II | Same |
| 10 | Indications foruse | The Self-adhesive Electrode isintended to be used to transmitelectrical stimulation current to thepatient's skin. Example electricalstimulations for currentapplications of the electrodes are:TENS and EMS. | The self-adhesive electrode isintended to be used to applyelectrical stimulation current tothe patient's skin. Exampleelectrical stimulations forcurrent applications of theelectrodes are: TENS and EMS. | Same |
| 11 | Targetpopulation | Single patient use and multipleapplication | Single patient use and multipleapplication | Same |
| 12 | Type of use | OTC and Prescription use | OTC and Prescription use | Same |
| 13 | Design (shape &connection) | Round, Rectangle, Elliptical,Calabash, Butterfly, Palm shapeaccording to customizedspecification.Lead wire with female socket, orsnap button with male snapconnector. | Round, Rectangle, Oval, Gourd,Butterfly, Saddle according tocustomized specification.Lead wire with female socket. | Similar |
| 14 | Materials | - Non-woven fabric tape- Polyurethane (PU) electricallyconductive carbon cloth (HebeiKangshengda ElectronicTechnology Co., Ltd)- Biocompatible conductivehydrogel coupling media(ValueTrode Carbon, K970426) | - Non-woven fabric tape- Electrically conductive carboncloth (ValueTrode Carbon,K970426)- Biocompatible conductivehydrogel coupling media(ValueTrode Carbon, K970426) | Similar |
| 15 | Electrode PadSize | Round Min.Ø20mm;Max.Ø85mm | Round Min.Ø20mm;Max.Ø80mm | Similar |
| Rectangle Min.26×26mm;Max.190×110mm | Rectangle Min.3×10mm;Max.80×130mm | |||
| Elliptical Min.85×45mm; | Oval Min.50×120mm; |
6. Substantially Equivalent Comparison Conclusion
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| Max.240×100mm | Max.100×240mm | |||||
|---|---|---|---|---|---|---|
| CalabashMin.90×47mm;Max.200×88mm | Gourd | Min.85×50mm;Max.170×100mm | ||||
| ButterflyMin.73×53mm;Max.195×95mm | Butterfly | Min.55×75mm;Max.95×165mm | ||||
| Palm shape74×47mm | Saddle | Min.75×110mm;Max.150×220mm | ||||
| 16 | ElectrodeImpedance ofElectrode Pad | Round | 302~577Ω | Round | 290~1000Ω | Similar |
| Rectangle | 303~646Ω | Rectangle | ||||
| Elliptical | 407~676Ω | Oval | ||||
| Calabash | 401~602Ω | Gourd | ||||
| Butterfly | 402~626Ω | Butterfly | ||||
| Palm shape | 402~638Ω | Saddle | ||||
| 17 | --Patient contactarea of electrode | Round | Min.3.14cm²;Max.56.716cm² | Round | Min.3.14cm²;Max.50.24cm² | Similar |
| Rectangle | Min.6.76cm²;Max.209cm² | Rectangle | Min.0.3cm²;Max.104cm² | |||
| Elliptical | Min.38.25cm²;Max.240cm² | Oval | Min.60cm²;Max.240cm² | |||
| Calabash | Min.42.3cm²;Max.176cm² | Gourd | Min.42.5cm²;Max.170cm² | |||
| Butterfly | Min.38.69cm²;Max.185.25cm² | Butterfly | Min.41.25cm²;Max.156.75cm² | |||
| Palm shape | 34.78cm² | Saddle | Min.82.5cm²;Max.330cm² | |||
| 18 | Max. currentDensity ofElectrode (UseIRMS=10mA forcalculation ) | Round | 3.18mA/cm²(Ø20mm: 3.14cm²) | Round | 3.18mA/cm²(Ø20mm:3.14cm²) | Similar |
| Rectangle | 1.48mA/cm²(26×26mm: 6.76cm²) | Rectangle | 33.3mA/cm²(3×10mm:0.3cm²) | |||
| Elliptical | 0.52mA/cm²(85×45mm/2:19.13cm²) | Oval | 0.17mA/cm²(50×120mm:60cm²) | |||
| Calabash | 0.24mA/cm²(90×47mm: 42.3cm²) | Gourd | 0.24mA/cm²(85×50mm:42.5cm²) | |||
| Butterfly | 0.52mA/cm²(73×53mm/2:19.35cm²) | Butterfly | 0.48mA/cm²(55×75mm/2:20.625cm²) | |||
| Palm shape | 0.29mA/cm²(74×47mm:34.78cm²) | Saddle | 0.24mA/cm²(75×110mm/2:41.25cm²) | |||
| 19 | Hydrogel | 35mils ± 5mils (0.89mm ± | 35mils ± 5mils (0.89mm ± | Same |
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| thickness | 0.13mm) | 0.13mm) | ||
|---|---|---|---|---|
| 20 | Hydrogel pH | 4.2 ± 1.0 | 4.2 ± 1.0 | Same |
| 21 | Hydrogelvolumeresistivity | 1500 ohm-cm max | 1500 ohm-cm max | Same |
| 22 | Standards meet | • Lead wires test per 8.5.2.3 ofAAMI/ANSI ES 60601-1;• Impedance test, Conformabilitytest and Fluid tolerance test per201.15.101.6 and 201.15.101.7 ofANSI AAMI IEC 60601-2-2Edition 6.0 2017-03;• Impedance Test (Dispersion Test)according to FDA's requirement;• Peeling force test and Simulationuse test according tomanufacturer's requirement;• Shelf life test per ASTMF1980:2016 | ISO14971;ISO 13485;EN 980;ANSI/AAMI EC12;IEC 60601-1. | Similar |
| 23 | Biocompatibility | ISO10993-5; ISO10993-10 | ISO10993-5; ISO10993-10 | Same |
| 24 | Sterility Status | Non-sterile | Non-sterile | Same |
| 25 | Electrical safety | Lead wire meets Clause 8.5.2.3 ofAAMI/ANSI ES60601-1 | Lead wire meets IEC 60601-1 | Same |
| 26 | OtherPerformance | Good electrical conductivity, goodadhesive property | Good electrical conductivity,good adhesive property | Same |
7. Conclusions
Based on the conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the legally marketed devices identified in the submission. Thus the subject device is substantially equivalent to the predicate device K090198.
§ 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).