(106 days)
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Not Found
No
The description focuses solely on the physical characteristics and intended use of conductive electrodes for electrotherapy, with no mention of AI or ML capabilities.
Yes
Explanation: The device is an electrode indicated for use with legally marketed TENS, EMS, or NMES devices, which are forms of electrotherapy used for therapeutic purposes such as pain relief and muscle stimulation.
No
The device, "Conductive carbon film electrode," is described as a cutaneous electrode intended to deliver pulses generated by electrotherapy stimulators (TENS, EMS, NMES devices) to the body surface. Its function is to transmit electrical signals for therapeutic purposes, rather than to gather information for diagnosis.
No
The device description explicitly states it is a "Conductive carbon film electrode" and "non-sterile reusable conductive garments," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that the Conductive carbon film electrodes are "cutaneous electrodes" intended to "deliver the pulses generated by the electrotherapy stimulator to the body surface." This indicates direct interaction with the body surface for therapeutic purposes (TENS, EMS, NMES), not for analyzing samples taken from the body.
- Intended Use: The intended use is to be used with TENS, EMS, or NMES devices, which are electrotherapy devices used for pain relief, muscle stimulation, etc. This is a therapeutic application, not a diagnostic one.
Therefore, the device described is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
GXY
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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