(87 days)
No
The device description and performance studies focus solely on the physical and electrical properties of the electrodes, with no mention of AI or ML technologies.
No
The device is a component (electrodes) used with electrical stimulators (e.g., TENS, EMS), but it is not a therapeutic device itself. Its purpose is to facilitate the transmission of electrical current from a therapeutic device to the patient's skin.
No.
This device acts as a reusable, conductive interface for transmitting electrical current from electrical stimulators (like TENS, EMS) to the patient's skin for therapeutic purposes, rather than diagnosing a medical condition.
No
The device description clearly outlines physical components like fabric, conductive film, hydrogel, and connectors, indicating it is a hardware device.
No, 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. These tests are performed outside of the living body (in vitro).
- Device Function: The ZMI Self-adhesive electrodes are used to transmit electrical current into the patient's body for therapeutic purposes (electrical stimulation). They are a conductive interface applied to the skin, not a device that analyzes samples taken from the body.
- Intended Use: The intended use clearly states they are for use with electrical stimulators for transmitting electrical current, not for diagnostic testing of biological samples.
The device description and performance studies also focus on the physical and electrical properties of the electrodes for their intended use in electrical stimulation, not on their ability to detect or measure substances in biological samples.
N/A
Intended Use / Indications for Use
ZMI Self-adhesive electrodes are intended for use as a reusable, conductive 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 electrodes are for OTC (Over-The-Counter) or Prescription use.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
ZMI Self-adhesive electrodes provide a means for establishing electrical contact between the lead connected to a TENS, EMS or NMES stimulation device and the skin, and are multi-layer, reusable, flexible structures composed of laminated materials commonly used in the application:
Top laver: Insulation material: Fabric/foam/tan fabric
Middle layer: Conductive film (Silver coated Carbon film/Aluminum foil film)
Bottom layer: Biocompatible self-adhesive conductive hydrogel
Connection: Leadwire/snap button/magnetic button
The electrodes are designed for single-patient & multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
Indicated Patient Age Range
General [Adult]
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)
Electrical performance was evaluated by measuring the AC impedance and current dispersion across the surface of the electrodes. Adhesive performance was evaluated by performing a repeated skin adhesion test. Electrode stability was evaluated by assessing electrical performance under normal use conditions. The electrical properties of the connectors were evaluated by measuring the resistance of the connection retention retention force. Biocompatibility evaluation for ZMI self-adhesive electrodes was done according FDA Good Manufacturing Practice & ISO 10993-1. The following tests were identified and done: Cytotoxicity, Irritation, Sensitization.
No clinical tests were needed.
Verification testing of the ZMI self-adhesive electrical and mechanical tests to show that it meets its target specifications over a range of operating and storage conditions. Verification and performance testing further demonstrated that it meets user needs as reflected in the functional specification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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June 28, 2018
ZMI Electronics, Ltd. Yuta Lee President 6F-1, 286-4, Shin Ya Road Kaohsiung, 806 TW
Re: K180865
Trade/Device Name: ZMI Self-Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: February 23, 2018 Received: April 2, 2018
Dear Yuta 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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good
1
manufacturing practice requirements as set forth in the quality systems (OS) 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 comprehensive regulatory information about medical devices and radiation-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,
William J. Heetderks -S 2018.06.28 13:45:12 -04'00'
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
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Indications for Use
510(k) Number (if known) K180865
Device Name ZMI Self-Adhesive Electrodes
Indications for Use (Describe)
ZMI Self-adhesive electrodes are intended for use as a reusable, conductive 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 electrodes are for OTC (Over-The-Counter) or Prescription use.
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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510k Summary
Device 510k number: K180865
Submitter Information
ZMI Electronics, Ltd. 6F-1, 286-4, Shin-Ya Road, Kaohsiung, Taiwan 806 Tel: +886-7-8150053 Fax: +886-7-8150057 Contact person: Wayne Chen, Sales Manager Date: June 6, 2018
FDA Registration Number
Owner/Operator Number: 9035676 Establishment Registration Number: 9617486
Regulatory Information
Trade name: ZMI Self-Adhesive Electrodes Common Name: Reusable Neurostimulation Electrodes Classification Name: Electrodes, cutaneous Regulation Number: 882.1320 Product Code: GXY Classification: Class II
Predicate Devices:
K132998 Wandy self-adhesive electrodes (WANDY Rubber Industrial Co., Ltd.) *Primary Predicate K160138 Adhesive Electrodes (GMDASZ Manufacturing Co., Ltd.)
Device Description
ZMI Self-adhesive electrodes provide a means for establishing electrical contact between the lead connected to a TENS, EMS or NMES stimulation device and the skin, and are multi-layer, reusable, flexible structures composed of laminated materials commonly used in the application:
Top laver: Insulation material: Fabric/foam/tan fabric Middle layer: Conductive film (Silver coated Carbon film/Aluminum foil film) Bottom layer: Biocompatible self-adhesive conductive hydrogel Connection: Leadwire/snap button/magnetic button
The electrodes are designed for single-patient & multiple application use. Because of the adhesive nature of the biocompatible conductive hydrogel, no securing materials are required to secure the device to the patient's skin.
Indications for Use
ZMI Self-adhesive electrodes are intended for use 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 electrodes are for OTC (Over-The-Counter) or Prescription use.
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Comparison to predicate device:
| Element of Comparison | Subject Device (K180865) | Predicate Device (K132998) | Comment |
|---|---|---|---|
| Company | ZMI Electronics, Ltd. | Wandy Rubber Industrial Co. Ltd | N/A |
| Device Name | ZMI Self-adhesive electrodes | Wandy Self-adhesive electrodes | N/A |
| Model name | SAE Type | Type A, Type P, Type M | N/A |
| Shape | Round, Rectangular, Square, Oval, and Butterfly | Round, Rectangular, Square, Oval, and Butterfly | Same |
| Color | White, Red, Black, and Tan | White, Red, Black, and Tan | Same |
| Regulation Number | 882.1320 | 882.1320 | Same |
| Product Code | GXY | GXY | Same |
| Classification Name | Cutaneous electrode | Cutaneous electrode | Same |
| Intended Use | ZMI Self-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, for OTC (Over-The-Counter) or Prescription use. | Wandy Self-adhesive Electrode is intended to transmit electrical current to patient skin for TENS (Transcutaneous Electrical Nerve- Stimulation) and EMS (Electrical muscular Stimulation) application, for OTC (Over-the- Counter) or Prescription use. The electrodes are used for adults only. | SE |
| OTC or Prescription | OTC and Prescription | OTC and Prescription | Same |
| Target Population | General [Adult] | General [Adult] | Same |
| Design Feature | Three layers: |
- Insulation backing material: Fabric/Foam/Tan fabric
- Conductive film: Aluminum foil film /Carbon film/Carbon film coated with silver/
- Conductive hydrogel | Three layers:
- Insulation backing material: Woven Fabric/Foam
- Conductive film: Aluminum foil film /Carbon film/Carbon film coated with silver/
- Conductive hydrogel | 1. SE The fabric and foam are commonly used for insulation cover on adhesive electrodes. The fabric material includes the synthetic fibers and natural fibers. Both fiber types can fulfill the insulation property, which won't raise any concerns of safety or effectiveness.
- Same
- Same |
| Electrical Connection | Leadwire
Snap button
Magnetic button | Leadwire
Snap button | Same
Same
SE The magnetic button provides another type of |
| | | | source of stimulation
current via magnetic
force among male and
female connectors. This
is similar to the other
connection methods like
leadwires & snap
buttons. No new
concerns of safety or
effectiveness are raised. |
| Lead Wire
connector | Leadwire connector .080"
(2mm) female socket
connector | Leadwire connector .080"
(2mm) female socket
connector | Same |
| Non-sterile | Non-sterile | Non-sterile | Same |
| Reusable | Reusable | Reusable | Same |
| Packaging | Re-sealable bag packed | Re-sealable bag packed | Same |
| Adhesive Type | Self-adhesive | Self-adhesive | Same |
| Biocompatibility | Complies with ISO10993 | Complies with ISO10993 | Same |
| A.C. Impedance |