Conductive carbon film electrode

K231164 · Guangzhou Xinbo Electronic Co., Ltd. · GXY · Aug 9, 2023 · Neurology

Device Facts

• Record ID: K231164
• Device Name: Conductive carbon film electrode
• Applicant: Guangzhou Xinbo Electronic Co., Ltd.
• Product Code: GXY · Neurology
• Decision Date: Aug 9, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Conductive carbon film electrode are cutaneous electrodes to be used with legally marketed TENS, EMS or NMES devices. The Conductive carbon film electrodes are non-sterile reusable conductive garments that are intended to deliver the pulses generated by the electrotherapy stimulator to the body surface with which they are in contact. These body parts can include the upper limb including wrist and hand, elbow or shoulder, lower and upper back, lower limb including hip, knee, leg, ankle and feet, and the back of the neck.

Device Story

Conductive carbon film electrodes are non-sterile, reusable conductive garments; designed to interface with legally marketed TENS, EMS, or NMES devices. Device receives electrical pulses from external electrotherapy stimulator; transmits pulses to patient's skin surface via conductive carbon film. Used on various body regions including limbs, back, and neck. Operated by patient or clinician; facilitates delivery of therapeutic electrical stimulation for pain management or muscle stimulation. No internal processing or active components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Passive conductive carbon film electrode; non-sterile, reusable garment form factor. Functions as a passive interface for TENS/EMS/NMES devices. No internal energy source, software, or active circuitry.

Indications for Use

Indicated for use as cutaneous electrodes with TENS, EMS, or NMES devices to deliver electrical pulses to body surfaces including limbs, back, and neck.

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.

Submission Summary (Full Text)

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August 9, 2023

Guangzhou Xinbo Electronic Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu Distric Guangzhou, Guangdong 511450 China

Re: K231164

Trade/Device Name: Conductive carbon film electrode Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: May 15, 2023 Received: May 15, 2023

Dear 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. 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.

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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) 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 mediation-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.

# Tushar Bansal -S

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) K231164

Device Name Conductive carbon film electrode

#### Indications for Use (Describe)

Conductive carbon film electrode are cutaneous electrodes to be used with legally marketed TENS, EMS or NMES devices. The Conductive carbon film electrodes are non-sterile reusable conductive garments that are intended to deliver the pulses generated by the electrotherapy stimulator to the body surface with which they are in contact. These body parts can include the upper limb including wrist and hand, elbow or shoulder, lower and upper back, lower limb including hip, knee, leg, ankle and feet, and the back of the neck.

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

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