(88 days)
Not Found
No
The device description and performance studies focus solely on the physical and electrical properties of the electrode pads, with no mention of AI or ML capabilities.
No.
The device itself, ELECTRODES PAD, is explicitly stated to transmit electrical current for use with legally marketed electrical stimulation devices (TENS and EMS), which are the therapeutic devices. The pad is a component that enables the therapy, but it does not independently provide the therapeutic electrical stimulation.
No
The device description clearly states its purpose is to transmit electrical current for stimulation (TENS, EMS), not to diagnose conditions.
No
The device description explicitly details physical components like insulation backing, adhesive tape, conducting film, hydrogel, lead wire, and snap, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation)." This describes a device used for therapeutic or stimulation purposes on the body, not for examining specimens derived from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description focuses on the physical components and how they transmit electrical current to the skin. There is no mention of analyzing biological samples or providing diagnostic information.
- Performance Studies: The performance studies listed (Biocompatibility, Delivery Test, Adhesion Test, Dispersion and Shelf Life Test) are related to the physical and electrical properties of the electrode and its interaction with the skin, not to the analysis of biological specimens.
- Key Metrics: The key metrics (Electrical impedance, Adhesive performance) are also related to the device's function in transmitting electrical current and adhering to the skin, not to diagnostic measurements.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., to provide information about a person's health status. This device does not perform such tests.
N/A
Intended Use / Indications for Use
ELECTRODES PAD is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The PAD is for OTC (Over-The-Counter) or Prescription use. The PAD is for adults only.
Product codes
GXY
Device Description
ELECTRODES PAD transmit electrical current to patient skin, the electrical current is first transmitted via the snap button or lead wire then transmitted to the conductive hydrogel which is adhered to patient skin. The PAD is for adults only. And the PAD is designed for single-patient and multiple application use. Both the leadwire type electrode and snap type electrode have six basic components: an insulation backing layer (Non-woven /PU /PVC /PET /EVA foam /silicone), a double sides adhesive tape, conducting film (Conductive carbon film), hydrogel (Conductive hydrogel), and plastic film (Protective film layer). The construction difference between both is the electrical connection layer: leadwire type uses carbon fiber wire, and snap type uses stainless steel for the snap. The device has an electrical impendence of
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of the HHS logo is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 14, 2019
Shenzhen Bestpad Technology Development Co., Ltd % Rain Yip Registered Engineer Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg. 1 Southward Ruifeng Business Center, Guimiao Road Shenzhen, Guangdong, 518000 Cn
Re: K190700
Trade/Device Name: Electrodes Pad Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: February 25, 2019 Received: March 18, 2019
Dear Rain Yip:
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Vivek Pinto, 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) K190700
Device Name ELECTRODES PAD
Indications for Use (Describe)
ELECTRODES PAD is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The PAD is for OTC (Over-The-Counter) or Prescription use. The PAD is for adults only.
| Type of Use (Select one or both, as applicable) | Depository Use (Part 21 CFR 601 Subpart D) On-Site Control Use (21 CFR 601 Subpart G) | Depository Use (Part 21 CFR 601 Subpart D) | On-Site Control Use (21 CFR 601 Subpart G) | ||
|---|---|---|---|---|---|
| Depository Use (Part 21 CFR 601 Subpart D) | |||||
| On-Site Control Use (21 CFR 601 Subpart G) |
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
"510(k) Summary" as required by 21 CFR Part 807.92.
Date: 2019-02-25
I. Submitter
Shenzhen Bestpad Technology Development Co., Ltd A16A17 Dong Jing Run Factory A301, Fourth Industrial Zone, Tantou Community, Songgang Street, Bao'an District, Shenzhen City, China
Tel.: +86 755 8259 3905 Tax: +86 755 8259 1544
Junwei Xu (General Manager) Tel: +86 135 1049 0026 Email: 843216888@qq.com
II. Device
Type of 510(k): Traditional Trade Name: ELECTRODES PAD Models: leadwire type electrode and snap type electrode Common Name: Cutaneous Electrode Classification Name of the device: Cutaneous Electrode Review Panel: Neurology Regulatory Class: II Product Code: GXY Regulation Number: 21 CFR 882.1320
III. Predicate Device
| Applicant | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| ShenZhen Quality Medical | |||
| Technology Co., Ltd | Adhesive Electrodes | K171381 | Dec.13, 2017 |
| Wandy Rubber Industrial | |||
| Co., Ltd | Wandy Self-adhesive | ||
| Electrode | K132998 | Dec.20, 2013 |
IV. Device Description
ELECTRODES PAD transmit electrical current to patient skin, the electrical current is first transmitted via the snap button or lead wire then transmitted to the conductive hydrogel which is adhered to patient skin.
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ELECTRODES PAD is intended to transmit electrical current to patient skin for use with legally marketed electrical stimulation devices, i.e. TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation). The PAD is for OTC (Over-The-Counter) or Prescription use. The PAD is for adults only. And the PAD is designed for single-patient and multiple application use.
| 1) Device specifications | ||||
|---|---|---|---|---|
| Model | Electrical connection method | Insulation backing material(s) | Product size (mm) | Connector size (Hole diameter) (mm) |
| Leadwire type electrode | Leadwire | Non-woven /PU /PVC /PET /EVA foam /silicone | Length: 20~300 | |
| Width: 20~300 | ||||
| Height (thickness): 1~20 | 1.5, 2.0, 2.5, 3.0 | |||
| Snap type electrode | Snap button | Non-woven /PU /PVC /PET /EVA foam /silicone | Length: 20~300 | |
| Width: 20~300 | ||||
| Height (thickness): 1~20 | 3.2, 3.6, 3.8, 4.0, 4.2 |
1) Device specifications
- Device design
The leadwire type electrode and snap type electrode both have six basic components. See Figure 1 and Figure 2 for the structure picture of the both model.
Image /page/4/Figure/5 description: The image shows a diagram of a layered structure with labels indicating the different materials used. Layer 1 is labeled as "Non-woven /PU/PVC/PET/EVA /Silicone", layer 2 is "Double sides adhesive tape", layer 3 is "Conducting film", layer 4 is "Hydrogel", and layer 5 is "Plastic film". There is also a "Carbon fiber wire" labeled as layer 6.
Figure 1 The structure of leadwire type electrode
Image /page/4/Figure/7 description: The image shows an exploded view of a layered product. The layers are labeled with numbers and descriptions. Layer 1 is "Non-woven /PU/PVC/PET/EVA/Silicone", layer 2 is "Double sides adhesive tape", layer 3 is "Conducting film", layer 4 is "Hydrogel", layer 5 is "Plastic film", and layer 6 is "Snap".
Figure 2 The structure of snap type electrode
-
- Materials used
Both models are composed of an insulation backing layer, a double sides adhesive tape, conducting film, hydrogel and plastic film. The construction different between both is leadwire and snap.
- Materials used
Material of construction:
| Component | Description /Material of Construction |
|---|---|
| Insulation backing layer | □Non-woven/□PU/□PVC/□PET/□EVA |
5
| Component | Description /Material of Construction |
|---|---|
| foam/ silicone | |
| Double sides adhesive tape | This layer is used to connect the upper and |
| lower layers. | |
| Conducting film | Conductive carbon film |
| Gel | Conductive hydrogel |
| Protective film layer | Plastic film |
| Electrical connection layer | Leadwire: carbon fiber wire |
| Snap: stainless steel |
- Physical and performance characteristics of the device Electrical impendence: The lead wire part is compliance with 21 CFR 898 by IEC 60601-1:2005/A1:2012 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Subclause 8.5.2.3.
-
The Delivery Test Report has been conducted to verify the product properties before factory delivery according to the manufacturer's acceptance criteria.
-
The Adhesion Test Report has been conducted to verify the maximum use duration of the subject device according to the requirements of the AAMI EC 12_2000(R) 2010 -Section 5.4.
-
The Dispersion and Shelf Life Test Report has been conducted to verify the current dispersion and shelf-life of the subject device in the expiration date according to the requirements of the FDA Guidance -Shelf Life of Medical Device and ASTM F1980-07 Standard.
Summary
Based on the above performance as documented in this application. ELECTRODES PAD was found to have a safety and effectiveness profile that is similar to the predicate devices.
VIII. Conclusions
The subject device ELECTRODES PAD is to be concluded substantial equivalent to its predicate devices.