(87 days)
TENS (1,2,5,8,9,10,14,15,17,18,21,22,23): To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. PMS (3,4,6,7,11,12,13,16,19,20,24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Not Found
The provided document is an FDA 510(k) clearance letter for a TENS & PMS Unit (Model: YF1503). It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this type of document (a 510(k) clearance letter) does NOT contain the detailed information required to answer your specific questions regarding acceptance criteria and the study that proves the device meets those criteria.
510(k) clearances primarily focus on demonstrating substantial equivalence to a predicate device, based on similar intended use, technological characteristics, and safety/effectiveness data. While manufacturers submit data to support their claims, the FDA clearance letter itself does not typically include the full study design, raw performance metrics, sample sizes, ground truth establishment, or expert qualifications in the level of detail you've requested.
Therefore,Based on the provided FDA 510(k) clearance letter, I cannot provide the information requested in your prompt. This document indicates the device's clearance but does not contain the detailed study design, performance metrics, or acceptance criteria that would be found in the original submission or a separate clinical study report.
In summary, the provided text does not contain any of the following information:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- Information about standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How the ground truth for the training set was established.
To obtain this information, one would typically need access to the manufacturer's 510(k) submission summary, a separate clinical study report, or a labeling document if such performance claims were explicitly made.
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April 1, 2022
Shenzhen Yuehua Xinsen Technology Co., Ltd. Iris Fung Regulation Manager Guangdong Jianda Medical Technology Co., Ltd. 906 Room, Longxiang Garden, Tianhe District Guangzhou, Guangdong China
Re: K220005
Trade/Device Name: TENS & PMS Unit (Model: YF1503) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NUH. NGX Dated: December 23, 2021 Received: January 4, 2022
Dear Iris Fung:
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.
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
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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 Pamela Scott Assistant 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
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Indications for Use
510(k) Number (if known) K220005
Device Name TENS & PMS Unit (model: YF1503)
Indications for Use (Describe)
TENS (1,2,5,8,9,10,14,15,17,18,21,22,23):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
PMS (3,4,6,7,11,12,13,16,19,20,24):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
| 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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§ 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).