(475 days)
Not Found
Not Found
No
The summary describes passive electrodes for delivering electrical stimulation and contains no mention of AI, ML, image processing, or data analysis that would suggest AI/ML is incorporated.
Yes
The device is described as electrodes intended for use with electrical stimulation devices like TENS or PMS, which are therapeutic devices used to deliver stimulation signals for pain relief or muscle stimulation.
No
The device is described as electrodes intended to deliver stimulation signals from legally marketed electrical stimulation devices (TENS or PMS) to the feet. This function is for delivering therapy, not for diagnosing a condition.
No
The device is described as "Cutaneous Electrodes," which are physical components intended to deliver electrical stimulation. This indicates a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the electrodes are used with electrical stimulation devices (TENS or PMS) to deliver signals to the feet. This is a therapeutic or pain management application, not a diagnostic one.
- Lack of Diagnostic Activity: IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such examination of biological specimens.
- Anatomical Site: The device is applied to the bottom of the feet, which is an external application for delivering electrical stimulation, not for collecting or analyzing biological samples.
The description focuses on the delivery of electrical signals for therapeutic purposes, which is outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Cutaneous Electrodes, Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-II, CP-III), are intended to be used with legally marketed electrical stimulation devices such as transcutaneous electrical nerve stimulators (TENS) or powered muscle stimulators (PMS). The cutaneous electrodes will deliver the stimulation signals generated by the stimulator to the bottom of the feet which they are in contact with.
Product codes
GXY
Device Description
Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-III)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bottom of the feet
Indicated Patient Age Range
Not Found
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)
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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.
May 13, 2020
Guangzhou Xinbo Electronic Co., Ltd. % Cassie Lee Manager Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road Huangpu District Guangzhou, Guangdong 511400 China
Re: K190118
Trade/Device Name: Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-III) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: February 29, 2020 Received: April 14, 2020
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 medical devices and radiation-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.
For Vivek Pinto, PhD Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K190118
Device Name
Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III)
Indications for Use (Describe)
The Cutaneous Electrodes, Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-II, CP-III), are intended to be used with legally marketed electrical stimulation devices such as transcutaneous electrical nerve stimulators (TENS) or powered muscle stimulators (PMS). The cutaneous electrodes will deliver the stimulation signals generated by the stimulator to the bottom of the feet which they are in contact with.
Type of Use (Select one or both, as applicable)
| Research Use (Part 21 CFR 601.21, Subpart B) | Gene Therapy Studies (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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