(28 days)
V2 OTC Pain Relief TENS is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
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I am sorry, but the provided text from the FDA 510(k) clearance letter for the "V2 OTC Pain Relief TENS" device (K182767) does not contain the detailed information necessary to answer your request.
The letter is a standard FDA clearance document. It confirms that the device is substantially equivalent to a predicate device and outlines general regulatory provisions. It does not include:
- A table of acceptance criteria and reported device performance.
- Details about sample size, data provenance, or types of studies conducted (e.g., test set, training set).
- Information on expert establishment of ground truth, adjudication methods, or MRMC studies.
- Specifics on standalone algorithm performance or the type of ground truth used.
For a medical device like a TENS unit, the primary "study" proving it meets acceptance criteria for substantial equivalence typically involves demonstrating that its technological characteristics (e.g., electrical stimulation parameters, waveform, output intensity) are substantially equivalent to a legally marketed predicate device, and that it performs as intended for its indicated use (temporary pain relief). This is usually supported by:
- Bench testing: To confirm electrical output specifications.
- Performance testing: To ensure it functions as described.
- Biocompatibility testing: If applicable, for patient contact materials.
- Electrical safety and EMC testing: To comply with relevant standards.
The letter itself does not detail these specific tests or their results, nor does it refer to studies involving AI, image analysis, or complex algorithms that would require the kind of detailed information about ground truth, expert consensus, MRMC studies, or training/test sets that you are asking for. Your questions are highly relevant for AI/ML-based medical devices, but this document pertains to a traditional electrical stimulation device for pain relief.
Therefore, I cannot populate the table or answer the specific questions about the study design using the provided text.
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October 26, 2018
Everyway Medical Instruments Co., Ltd. % Aaron Hage Associate Attorney DuVal & Associates 825 Nicollet Mall, Suite 1820 Minneapolis, Minnesota 55402
Re: K182767
Trade/Device Name: V2 OTC Pain Relief TENS Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: September 26, 2018 Received: September 28, 2018
Dear Aaron Hage:
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 mav, 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 avare 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-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.
Pamela D. Scott -S
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) K182767
Pain Relief TENS
Indications for Use (Describe)
V2 OTC Pain Relief TENS is intended for temporary relief of pain associated with sore and aching muscles in the low back as well as upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
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).