(87 days)
Not Found
No
The device description and intended use are solely focused on the physical properties and function of a self-adhesive electrode for transmitting electrical current, with no mention of AI or ML capabilities.
Yes
The device is described as an accessory for TENS (Transcutaneous Electrical Nerve Stimulation) and EMS (Electrical Muscular Stimulation) applications, which are therapeutic modalities.
No
Explanation: The device is an electrode intended to transmit electrical current for therapeutic applications (TENS and EMS), not for diagnosing medical conditions.
No
The device description explicitly states it is a "Self-adhesive Electrode" and describes physical components like "lead wire or snap button" and "conductive gel," indicating it is a hardware device.
Based on the provided information, the Wandy Self-adhesive Electrode is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Wandy Electrode Function: The Wandy Self-adhesive Electrode is designed to transmit electrical current to the patient's skin for therapeutic purposes (TENS and EMS). It does not analyze any biological samples taken from the patient.
- Intended Use: The intended use clearly states its application for TENS and EMS, which are external electrical stimulation therapies.
Therefore, the Wandy Self-adhesive Electrode falls under the category of a medical device used for external therapy, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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) applications, for OTC (Over-The -Counter) or Prescription use. The Electrode are used for adults only.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
Wandy Self-adhesive Electrodes 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 Wandy Self-adhesive Electrodes transmits electrical current to patient skin, the electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin.
The Wandy Self-adhesive Electrodes is used as an accessory with the TENS or EMS device units.
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 Wandy Self-adhesive Neurostimulation Electrode passed self-evaluation tests for Impedance, Wire pull and adhesiveness.
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.
Wandy Self adhesive Neurostimulation electrode (K002219), Wandy Silicon Conductive Rubber Pad (K002227), Jiajian Self- adhesive Electrode (K090198)
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.
Not Found
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).
0
DEC 2 0 2013
K132998
Chapter 5- 510(K) Summary
| Submitter | Janis Yang |
|---|---|
| Wandy Rubber Industrial Co., Ltd | |
| No.48, Lane 392, Fu Teh 1Rd, Shi-Chih City 221, Taipei | |
| Taiwan | |
| Tel: +886-2-26943185 | |
| Fax: +886-2-26944574 | |
| Proprietary Name | Wandy Self-adhesive Electrodes |
| Common Name | Cutaneous electrode. |
| Classification Name | Cutaneous electrode. |
- Panel
Neurology
Classification
| classification name | 21 CFR
section | Product code | Class |
|---------------------|-------------------|--------------|-------|
| Cutaneous electrode | 882.1320 | GXY | II |
Predicate Device_
Wandy Self adhesive Neurostimulation electrode (K002219) Wandy Silicon Conductive Rubber Pad (K002227) Jiajian Self- adhesive Electrode (K090198)
Description and Indication for 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) applications, for OTC (Over-The -Counter) or Prescription use. The Electrode are used for adults only.
The Wandy Self-adhesive Electrodes transmits electrical current to patient skin, the electrical current is first transmitted via the lead wire or snap button then transmitted to the conductive gel which is adhered to patient skin.
1
The Wandy Self-adhesive Electrodes is used as an accessory with the TENS or EMS device units.
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2
Substantial Equivalency
After analyzing both bench and clinical testing data, it is the conclusion of Wandy Self-adhesive Electrodes are substantial equivalent to the predicate device, Wandy Self adhesive Neurostimulation electrode (K002219), Wandy Silicon Conductive Rubber Pad (K002227) and Jiajian Self- adhesive Electrode (K090198).
Performance
The Wandy Self-adhesive Neurostimulation Electrode passed self-evaluation tests for Impedance, Wire pull and adhesiveness.
Discussion of Clinical Tests Performed:
All design specification are exactly equivalent between new devices (Wandy Self-adhesive Electrodes) and predicate devices (Wandy Self-Adhesive Neurostimulation Electrode and Wandy Silicon Conductive Rubber Pad), except claimed indication for use and proposed labeling. Two predicate devices have thousands of marketing clinical experience and didn't have adverse events occurred in the world.
Conclusions:
Wandy Self-adhesive Electrodes have the same intended use and similar technological characteristics as the above predicate devices. Moreover, information contained in this submission supplied demonstrates that any differences in their characteristics do not raise any new questions of safety or effectiveness. Thus, Wandy Self-adhesive Electrodes are substantially equivalent to the predicate devices
3
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2013
Wandy Rubber Industrial Co., Ltd. Jack Yu No.48, Lane 392, Fu Teh 1 Rd, Xi Zhi Dist New Taipei City Taiwan 221
Re: K132998
Trade/Device Name: Wandy Self-Adhesive Electrodes Regulation Number: 21 CFR 882.1320 Regulatory Class: Class II Product Code: GXY Dated: September 9, 2013 Received: September 24, 2013
Dear Mr. Yu:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
4
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours, Joyce M. Whang -S
Carlos L. Peña. PhD for Director Division of Neurological and Physical Medicine Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K132998
Device Name: Wandy Self-Adhesive Electrodes
Indications For 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) applications, for OTC (Over-The -Counter) or Prescription use. The Electrode are used for adults only.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use × (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
Joyce M. Whang -S
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