(256 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or related concepts, and the device description is for a standard electrical stimulator.
Yes
The device is intended for the temporary relief of pain associated with sore and aching muscles, which is a therapeutic purpose.
No
The device is described as providing "temporary relief of pain associated with sore and aching muscles," which indicates a therapeutic rather than a diagnostic purpose.
No
The device description explicitly states "Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01," which indicates a hardware component for electrical stimulation, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as providing temporary relief of pain associated with sore and aching muscles. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is described as a Transcutaneous Electrical Applicator (TEA). This type of device delivers electrical stimulation to the skin for therapeutic purposes.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (like blood, urine, or tissue), detecting diseases or conditions, or providing diagnostic information.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
To be used by adults only for temporary relief of pain associated with sore and aching muscles in the shoulder, wast, back, neck, arm, and leg, due to strain from exercise or normal household work activities and suitable for home use.
Product codes
NUH
Device Description
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Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
shoulder, wast, back, neck, arm, and leg
Indicated Patient Age Range
adults only
Intended User / Care Setting
home use
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
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
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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 23, 2022
Ningbo MedKinetic Medical Device Co., Ltd. % Zhang Wei Manager Shenzhen Reanny Medical Devices Management Consulting Co Ltd Ningbo MedKinetic Medical Device Co., Ltd. Lushan West Road 167-8, Ningbo Free Trade Zone (South) Ningbo, Zhejiang 315806 China
Re: K212377
Trade/Device Name: Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH
Dear Zhang Wei:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 15, 2022. Specifically, FDA is updating this SE Letter (to correct a typo in the trade name) as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Heather Dean, OHT5: Office of Neurological and Physical Medicine Devices, (240) 402-9874, Heather.Dean@fda.hhs.gov.
Sincerely,
Heather L. Dean -S
Heather Dean, 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
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Image /page/1/Picture/0 description: The image contains 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.
April 15, 2022
Ningbo MedKinetic Medical Device Co., Ltd. % Zhang Wei Manager Shenzhen Reanny Medical Devices Management Consulting Co Ltd Ningbo MedKinetic Medical Device Co., Ltd. Lushan West Road 167-8, Ningbo Free Trade Zone(Sou Ningbo, Zhejiang 315806 China
Re: K212377
Trade/Device Name: Transcutaneous Electrical Applicator (TEA) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH Dated: March 12, 2022 Received: March 15, 2022
Dear Zhang Wei:
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.
2
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).
Image /page/2/Picture/5 description: The image shows a signature block. It includes the name "Pamela D. Scott -S" and the word "Sincerely,". There is also a digital signature with the date "2022.04.15" and time "21:01:12 -04'00'".
Pamela D. Scott Assistant Director 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) K212377
Device Name
Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01
Indications for Use (Describe)
To be used by adults only for temporary relief of pain associated with sore and aching muscles in the shoulder, wast, back, neck, arm, and leg, due to strain from exercise or normal household work activities and suitable for home use.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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