Adhesive Electrodes

K170744 · Reno Medical , Ltd. · GXY · May 8, 2017 · Neurology

Device Facts

• Record ID: K170744
• Device Name: Adhesive Electrodes
• Applicant: Reno Medical , Ltd.
• Product Code: GXY · Neurology
• Decision Date: May 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.

Device Story

Adhesive electrodes serve as a disposable, conductive interface between patient skin and external electrical stimulators (TENS/EMS). The device consists of a substrate and wire, available in rectangular or round shapes. It is intended for single-patient use in home or hospital environments. By providing a conductive path, the electrodes allow electrical stimulation to be delivered to the patient for therapeutic purposes. The device is applied by the user or clinician to the skin surface, connecting to a stimulator to facilitate nerve or muscle stimulation.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Consists of substrate, wire, hydro-gel, scrim, conductive fiber, carbon conductive film, and liner. Available in rectangular and round form factors. Biocompatibility conforms to ISO 10993 series standards. Passive conductive interface; no energy source or software.

Indications for Use

Indicated for use as a disposable, conductive adhesive interface between patient skin and TENS or EMS electrical stimulators. Intended for OTC use by adults and children in home or hospital settings.

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

• Adhesive Electrodes (K132588)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three faces in profile, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Mav 8, 2017

Reno Medical Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 China

Re: K170744

Trade/Device Name: Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: March 4, 2017 Received: March 10, 2017

Dear Diana Hong:

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

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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 (reporting of medical devicerelated 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 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Michael J. Hoffmann -S

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

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## Indications for Use

510(k) Number (if known) K170744

Device Name Adhesive Electrodes

Indications for Use (Describe)

Adhesive electrodes are intended for use as the disposable, conductive interface between the patient's skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is 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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# Tab #7 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.

The assigned 510(k) Number: -

- 1. Date of Preparation: 2/20/2017
- 2. Sponsor Identification

### Reno Medical Ltd.

MNC2246 RM1007, 10/F, Ho King Comm CTR , 2-16Fa Yuen Street, Mongkok, KL. Hongkong, CHINA, 999077

Establishment Registration Number: 3008799799

Contact Person: LiMing Ren Position: Management Representative Tel: [phone] Fax: [phone] Email: [e-mail]

- Designated Submission Correspondent 3.
Ms. Diana Hong (Primary Contact Person) Ms. Betty Xiao (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

- 4. Identification of Proposed Device
Trade Name: Adhesive Electrodes Common Name: Electrode

Regulatory Information Classification Name: 882.1320 - Cutaneous electrode.

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Classification: II Product Code: GXY Regulation Number: 21 CFR 882.1320 Review Panel: Neurology

Intended Use Statement:

Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.

Device Description

Adhesive electrodes are intended for use as the disposable, conductive adhesive interface between the patient's skin and the Electrical Stimulator. Adhesive Electrodes are intended to be used with marketed Electrical Stimulators, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). It is for OTC use.

The proposed device, Adhesive Electrode, is intended to be used with U.S. legally marketed Electrical Stimulator, i.e. TENS and EMS, as a conductive adhesive interface between the patient's skin and such stimulators. It is for single patient use only.

The intended environment for the proposed device includes home use and hospital use. The intended population for the proposed device includes children and adults.

The proposed device mainly consists of substrate and wire. The substrate is available in rectangular shape and round shape.

- Identification of Predicate Device 5.
510(k) Number: K132588 Product Name: Adhesive Electrodes Manufacturer: Top-Rank Health Care Co., Ltd.

#### Non-Clinical Test Conclusion 6.

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device.

- 7. Clinical Test Conclusion
No clinical study is included in this submission.

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#### Ref.: M3702016

#### 8. Substantially Equivalent (SE) Comparison

The following table compares the DEVICE to the predicate device with respect to intended use, design feature and performance, etc

| Item | Proposed Device | Predicate Device |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Product Code | GXY | Identical |
| Regulation Number | 21 CFR 880.1320 | Identical |
| Class | II | Identical |
| Intended Use | Adhesive electrodes are intended for use as<br>the disposable, conductive adhesive interface<br>between the patient's skin and the Electrical<br>Stimulator. Adhesive Electrodes are intended<br>to be used with marketed Electrical<br>Stimulators, i.e. TENS (Transcutaneous<br>Electrical Nerve Stimulation) and EMS<br>(Electrical Muscular Stimulation). It is for<br>OTC use. | Identical |
| Design Feature | Substrate / Wire / Hydro-Gel<br>Scrim / Conductive Fiber<br>Carbon Conductive Film / Liner | Identical |
| OTC or<br>Prescription | For OTC use | Identical |
| Biocompatibility | Conforms to ISO 10993 series standards | Identical |
| Label/Labeling | Complied with 21 CFR part 801 | Identical |

Table 1 Comparison of Technology Characteristics

#### 9. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.