(216 days)
Not Found
No
The device description and performance studies focus on the physical and electrical properties of the electrodes, with no mention of AI or ML.
Yes
The intended use states that the device is for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications, which are therapeutic modalities.
No
The device transmits electrical current for therapeutic applications (TENS and EMS), not to diagnose a condition.
No
The device description clearly outlines physical components (EVA foam, conductive film, hydrogel, PET liner) and their function in transmitting electrical current, indicating it is a hardware device.
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 (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Adhesive Electrodes described here are used to transmit electrical current to the patient's skin for therapeutic purposes (TENS and EMS). They do not analyze samples taken from the body.
- Intended Use: The intended use clearly states the purpose is for TENS and EMS applications, which are external therapeutic treatments.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Adhesive Electrodes are intended to transmit electrical current to patient skin for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications. It is for OTC (Over-The -Counter) or Prescription use and is to be used for adults only.
Product codes
GXY
Device Description
The Adhesive Electrodes transmit electrical current to patient skin, the electrical current is first transmitted via the snap button then transmitted to the conductive gel which is adhered to patient skin.
Adhesive Electrodes are multi-layer reusable, flexible structures, composed of laminated materials commonly used in this application:
EVA foam First layer: Insulating backing material: Second layer: Conductive film: Carbon film Third layer: Biocompatible self-adhesive conductive hydrogel Protective liner: PET
The dimension of the adhesive electrode is 40 mm (L) × 70 mm (W) ×3mm (H).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient skin
Indicated Patient Age Range
adults only
Intended User / Care Setting
Not Found
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)
The proposed Electrode evaluated through Electrode Performance testing (Electrical Impedance Performance, Adhesive Performance, Current dispersion and Peel force ), Biocompatibility testing and Reuse testing.
The non-clinical tests demonstrated that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.
Sensitivity testing criteria as specified in ISO 10993-10 and cytotoxicity testing criteria as specified in ISO 10993-5.
ISO 14971:2007 Medical Device, Harm Control Application to Medical Device Shelf life testing according to FDA recognized standard ASTM F1980 - 16 (Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices)
No clinical study is needed to be included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's role in protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.
December 13, 2017
ShenZhen Quality Medical Technology Co.,Ltd % Jet Li Regulation Manager Guangzhou LETA Testing Technology Co., Ltd 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou. Guangdong, CN
Re: K171381
Trade/Device Name: Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: October 28, 2017 Received: November 6, 2017
Dear Jet Li:
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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting of medical device-related 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.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Vivek J. Pinto -S
for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171381
Device Name Adhesive Electrodes
Indications for Use (Describe)
The Adhesive Electrodes are intended to transmit electrical current to patient skin for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulations. It is for OTC (Over-The -Counter) or Prescription use and is to be used for adults only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
|X | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Date of the summary prepared: December 11, 2017
2. Submitter's Information
Sponsor:
510(k) Owner's Name: ShenZhen Quality Medical Technology Co.,Ltd
Establishment Registration Number: N/A
Address: 5/F, Plant C3, No.1, Nuclear Power Industrial Zone, Guanlan Shijing
Community,
Guanlan Street, Longhua New Area, Shenzhen, Guangdong
Phone: +86(755)29016583
Fax: +86(755)29016583
Contact Person: Grace Zhao
E-mail: qd0755@163.com
Application Correspondent:
Guangzhou LETA Testing Technology Co., Ltd. Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou
City.China
Contact Person: Mr. Jet Li Tile: Regulation Manager Tel: +86-18588874857 Email: med-jl@foxmail.com
3. Subject Device Information
- Adhesive Electrodes Trade Name: �
- Cutaneous electrode Common Name: �
4
- Classification name: Electrode, Cutaneous �
- � Review Panel: Neurology
- Product Code: GXY �
- Regulation Class: ll �
- Regulation Number: 882.1320 �
4. Predicate Device Information
Predicate Device 1
| Sponsor | Wandy Rubber Industrial Co., Ltd |
|---|---|
| Device Name | Wandy Self-adhesive Electrodes |
| 510(k) Number | K132998 |
| Product Code | GXY |
| Regulation Number | 882.1320 |
| Regulation Class | 2 |
Predicate Device 2
| Sponsor | GMDASZ Manufacturing Co., Ltd |
|---|---|
| Device Name | Adhesive Electrodes |
| 510(k) Number | K160138 |
| Product Code | GXY |
| Regulation Number | 882.1320 |
| Regulation Class | 2 |
5. Device Description
The Adhesive Electrodes transmit electrical current to patient skin, the electrical current is first transmitted via the snap button then transmitted to the conductive gel which is adhered to patient skin.
Adhesive Electrodes are multi-layer reusable, flexible structures, composed of laminated materials commonly used in this application:
5
EVA foam First layer: Insulating backing material: Second layer: Conductive film: Carbon film Third layer: Biocompatible self-adhesive conductive hydrogel Protective liner: PET
The dimension of the adhesive electrode is 40 mm (L) × 70 mm (W) ×3mm (H).
6. Intended Use / Indications for Use
The Adhesive Electrodes are intended to transmit electrical current to patient skin for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications. It is for OTC (Over-The -Counter) or Prescription use and is to be used for adults only.
7. Bench Testing (Non-clinical)
Compare to primary predicate devices specified in K132998 and K160138, our device and the predicate devices are same in, raw materials, physical features, and same manufacturing processes. The biocompatibility performance equivalence evidence of proposed electrode can be demonstrated according to ISO10993-1, ISO10993-5 and ISO10993-10.
The proposed Electrode evaluated through Electrode Performance testing (Electrical Impedance Performance, Adhesive Performance, Current dispersion and Peel force ), Biocompatibility testing and Reuse testing.
The non-clinical tests demonstrated that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.
8. Clinical Test Conclusion
No clinical study is needed to be included in this submission.
9. Test Summary
Sensitivity testing criteria as specified in ISO 10993-10 and cytotoxicity testing criteria as specified in ISO 10993-5.
ISO 14971:2007 Medical Device, Harm Control Application to Medical Device Shelf life testing according to FDA recognized standard ASTM F1980 - 16 (Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices)
6
10. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, mode of operation, and intended use of Electrode piece is substantially equivalent to the predicate devices quoted above.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements
of
| Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
|---|---|---|---|---|
| Characteristics | ||||
| Device Name and | ||||
| Model | Adhesive Electrodes | Wandy Self-adhesive | ||
| Electrodes | Adhesive | |||
| Electrodes | -- | |||
| 510 (K) Number | Applying | K132998 | K160138 | -- |
| Intended Use | The Adhesive | |||
| Electrodes are | ||||
| intended to transmit | ||||
| electrical current to | ||||
| patient skin for TENS | ||||
| (Transcutaneous | ||||
| Electrical Nerve | ||||
| Stimulation) and | ||||
| EMS (Electrical | ||||
| Muscular Stimulation) | ||||
| applications. It is for | ||||
| OTC (Over-The | ||||
| -Counter) or | ||||
| Prescription use and | ||||
| is to be used for | ||||
| adults only. | Wandy Self-adhesive | |||
| Electrode is intended to | ||||
| transmit electrical current | ||||
| to patient skin for | ||||
| TENS (Transcutaneous | ||||
| Electrical Nerve | ||||
| Stimulation) and EMS | ||||
| (Electrical Muscular | ||||
| Stimulation) applications, | ||||
| for OTC (Over-The | ||||
| -Counter) or Prescription | ||||
| use. The Electrode | ||||
| are used for adults only. | The adhesive | |||
| electrodes | ||||
| are intended for as a | ||||
| reusable, conductive | ||||
| adhesive interface | ||||
| between | ||||
| the patient's skin and | ||||
| the | ||||
| marketed electrical | ||||
| stimulators (i.e. | ||||
| TENS | ||||
| (Transcutaneous | ||||
| Electrical | ||||
| Nerve Stimulation), | ||||
| EMS | ||||
| (Electrical Muscular | ||||
| Stimulation), IF | ||||
| (Interferential) or | ||||
| PGF | ||||
| (Pulsed Galvanic | ||||
| Stimulation) for | ||||
| transmitting electrical | ||||
| current. The | ||||
| electrode is | ||||
| for OTC (Over-The- | ||||
| Counter) or | SE | |||
| Elements | ||||
| of | ||||
| Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
| Product Code | GXY | GXY | GXY | |
| Prescription use. | SE | |||
| Regulation | ||||
| Number | 882.1320 | 882.1320 | 882.1320 | SE |
| OTC or | ||||
| Prescription | OTC and Prescription | OTC and Prescription | OTC and | |
| Prescription | SE | |||
| Intended patient | ||||
| population | adults | adults | -- | SE |
| Single Patient Use | Single Patient Use | Single Patient Use | Single Patient Use | SE |
| Reusable | Reusable | Reusable | Reusable | SE |
| Design Feature | Three layers: |
- Insulation backing
material: EVA foam - Conductive film:
Carbon film
3.Conductive
hydrogel | Three layers: - Insulating backing
material: Woven
Fabric/Foam - Conductor:
Aluminum/Carbon - Conductive hydrogel | Three layers:
- Insulation backing
material:
Fabric/Foam/Tan
fabric - Conductive film:
Carbon film/Carbon
film coated with
silver/Aluminum foil
film - Conductive
hydrogel | SE |
| Protective Liner | PET | PET | PET | SE |
| Electrical
Connection | Snap button | Snap button or lead wire | Snap button or lead
wire | SE |
| Non-sterile | Non-sterile | Non-sterile | Non-sterile | SE |
| Reusable | Reusable | Reusable | Reusable | SE |
| A.C. Impedance |