Adhesive Electrode

K210448 · Shaoxing Yingtuo Healthcare Co., Ltd. · GXY · Aug 31, 2021 · Neurology

Device Facts

• Record ID: K210448
• Device Name: Adhesive Electrode
• Applicant: Shaoxing Yingtuo Healthcare Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: Aug 31, 2021
• 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 stimulator, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).

Device Story

Adhesive electrode acts as disposable, conductive interface between patient skin and electrical stimulators (TENS/EMS); device placed on skin and connected to stimulator via lead wires; electrical pulses pass through skin to activate underlying nerves; used in clinical or home settings; operated by patients or healthcare providers; output is electrical stimulation current; benefits include facilitating nerve/muscle stimulation for therapeutic purposes.

Clinical Evidence

Bench testing only. Biocompatibility (cytotoxicity, irritation, sensitization) per ISO 10993-1:2018; performance testing (pull test, conformability, fluid tolerance); shelf-life stability testing.

Technological Characteristics

Materials: non-woven fabric, adhesive, PVC-coated wire/terminal, hydrogel, PET fabric, carbon fiber, reinforcing fiber, poly-isobutylene, carbon black, graphite. Non-sterile, single-patient use. Dimensions vary (20mm to 180mm). Connectivity: wired interface to external stimulator.

Indications for Use

Indicated for use as a disposable, conductive adhesive interface between patient skin and electrical stimulators (TENS/EMS) to apply electrical stimulation current. Suitable for prescription and OTC use.

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

• TENS Electrodes (K160081)

Submission Summary (Full Text)

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August 31, 2021

Shaoxing Yingtuo Healthcare Co., Ltd. Haze XU Management Representative, Quality Department NO.176 Shungeng Road, Baiguan Street, Shangyu Area Shaoxing City, Zhejiang Province 312300 China

Re: K210448

Trade/Device Name: adhesive electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: July 29, 2021 Received: August 5, 2021

Dear Haze XU:

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/cfpm/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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Heather L. Dean -S

Heather Dean, PhD Assistant Director. Acute Injurv 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) K210448

Device Name adhesive electrode

#### 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 stimulator, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation).

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| <div> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> Over The Counter Use (21 CFR 801 Subpart C) </div> |

||X| 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

#### I Submitter

| 510(K) Number: | K210448 |
|-------------------|------------------------------------------------------------------------------------------------------|
| Device submitter: | Shaoxing Yingtuo Healthcare Co.,Ltd. |
| | NO.176 Shungeng Road, Baiguan Street, Shangyu<br>Area, Shaoxing City, Zhejiang Province, P.R. CHINA. |

- Contact person: Haze XU Phone:[phone] E-mail: [e-mail]
#### II Device

Trade Name of Device: adhesive electrode Common name: Cutaneous Electrode Classification: Class II, 21 CFR 882.1320 Product Code: GXY

#### III Predicate Device

| Trade name: | TENS Electrodes |
|-------------------------|---------------------------|
| Common name: | Cutaneous Electrode |
| Classification: | Class II, 21 CFR 882.1320 |
| Product Code: | GXY |
| Premarket Notification: | K160081 |
| Company name: | CATHAY MANUFACTURING CORP |

#### IV Device description

The adhesive electrode is placed onto human skin and connected with electrical stimulators by lead wires. The electrical pulses are passed across the intact surface of the skin to activate the underlying nerves.

#### V 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).

### VI Comparison of technological characteristics with the predicate devices

The adhesive electrode has the same intended use and principle operation, the technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the adhesive electrode and predicate devices do not alter suitability of the proposed device for its intended use.

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| | adhesive electrode<br>(subject device) | TENS Electrodes<br>K160081 (predicate device) | Discussion |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Device feature | (subject device) | K160081 (predicate device) | Discussion |
| Intended use | The proposed device is intended for<br>use as the disposable, conductive<br>adhesive interface between the<br>patient's skin and the electrical<br>stimulator to apply electrical<br>stimulation current, and is intended<br>to be used with marketed electrical<br>stimulators, i.e. TENS<br>(Transcutaneous Electrical Nerve<br>Stimulation) and EMS (Electrical<br>Muscular Stimulation). | 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 be<br>used with marketed electrical<br>stimulators, i.e. TENS<br>(Transcutaneous Electrical<br>Nerve Stimulation) and EMS<br>(Electrical Muscular<br>Stimulation). It's for OTC<br>use | Substantially<br>equivalent. |
| Surface area | (Length * width):<br>20mm*40mm, 22mm*22mm<br>25mm*35mm, 25mm*42mm<br>25mm*60mm, 30mm*40mm<br>30mm*50mm, 30mm*60mm<br>30mm*70mm, 32mm*32mm<br>40mm*40mm, 40mm*50mm<br>40mm*60mm, 40mm*70mm<br>40mm*80mm, 40mm*90mm<br>40mm*100mm, 40mm*110mm,<br>40mm*120mm, 40mm*130mm,<br>45mm*45mm, 45mm*55mm<br>45mm*60mm, 45mm*70mm<br>45mm*80mm, 45mm*90mm<br>45mm*100mm, 48mm*48mm<br>48mm*86mm, 50mm*50mm<br>50mm*60mm, 50mm*70mm<br>50mm*80mm, 50mm*90mm<br>50mm*100mm, 50mm*110mm<br>50mm*120mm, 50mm*130mm<br>55mm*55mm, 55mm*65mm<br>55mm*70mm, 55mm*75mm<br>55mm*80mm, 55mm*90mm<br>55mm*100mm, 55mm*110mm | Largest model:<br>CM100180FC (Rectangle<br>shape: 100 x 180 mm);<br>Smallest model:<br>CM2222FC(square shape: 22<br>x 22 mm);<br>Irregular representative:<br>CM2542YC(crescent ); | Substantially<br>equivalent.<br>The<br>surface area of<br>the device does<br>not<br>alter<br>its<br>intended use. |
| | adhesive electrode<br>(subject device) | TENS Electrodes<br>K160081 (predicate device) | Discussion |
| Device feature | 55mm*120mm, 55mm*130mm<br>60mm*60mm, 60mm*70mm<br>60mm*80mm, 60mm*90mm<br>60mm*100mm, 60mm*110mm<br>60mm*120mm, 60mm*130mm<br>65mm*65mm, 70mm*70mm<br>70mm*80mm, 70mm*90mm<br>70mm*100mm, 70mm*110mm<br>70mm*120mm, 70mm*130mm<br>75mm*75mm, 75mm*125mm<br>80mm*80mm, 80mm*100mm<br>80mm*110mm, 80mm*120mm<br>80mm*130mm, 85mm*85mm<br>85mm*180mm, 90mm*90mm<br>90mm*120mm, 90mm*130mm<br>100mm*120mm, 100mm*125mm<br>100mm*130mm, 100mm*140mm<br>100mm*180mm, 105mm*155mm<br>124mm*130mm. | | |
| | (Diameter):<br>22mm, 25mm, 32mm, 40mm,<br>45mm, 50mm, 55mm, 60mm,<br>65mm, 70mm, 75mm, 80mm,<br>85mm, 90mm | | |
| Components | Substrate/Wire/Hydrogel/Scrim/Conductive Fiber/Carbon conductive film/Liner | Substrate/Wire/Hydro-gel/Scrim/Conductive<br>Fiber/Carbon conductive film/Liner | Identical |
| Materials | Non-woven Fabric + Adhesive | Non-woven Fabric +<br>Adhesive | Identical |
| | Wire and Terminal coated PVC | Wire and Terminal coated<br>PVC | Identical |
| | Hydrogel | Hydro-gel | Identical |
| | PET Fabric | PET Fabric | Identical |
| | Carbon fiber + Reinforcing fiber | Carbon fiber + Reinforcing<br>fiber | Identical |
| | Poly-isobutylene, Carbon Black | Poly-isobutylene, Carbon... | Substantially |
| Device feature | adhesive electrode<br>(subject device) | TENS Electrodes<br>K160081 (predicate device) | Discussion |
| | Graphite, Additives | Black | equivalent. |
| Current(mArms) | 58.81 | Not Publicly Available | / |
| Charge( $ \mu $ C) | 17.40 | Not Publicly Available | / |
| power<br>densities(mW/mm2) | 448.32 | Not Publicly Available | / |
| Biocompatibility | Comply with ISO 10993 series | Comply with ISO 10993 series | Identical |
| Sterility | Non-sterile | Non-sterile | Identical |
| Re-usable | For single patient | For single patient | Identical |
| Shelf life | 3 years | 2 years | Substantially<br>equivalent. |

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# VII Summary of Non-clinical tests:

# Biocompatibility testing

Biocompatibility of the adhesive electrode was evaluated in accordance with ISO 10993-1:2018 for the body contact category of "Surface-contacting devices: Skin" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation and Sensitization. All evaluation acceptance criteria were met.

# Shelf life testing

The shelf life of the adhesive electrode is determined based on stability study which includes ageing test.

# Product performance testing

Performance testing includes pull test, conformability test, fluid tolerance testing, and Shelf-Life testing for both subject device and predicate device.

# VIII Conclusion

The adhesive electrode is substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.