(90 days)
TENS: 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.
EMS: intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that the EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance. The EMS may therefore be considered a technique of muscle training.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) and Electrical Muscle Stimulator (EMS) device (Model EM-5200). This type of device is an electrical stimulator, not an AI/ML-driven diagnostic or prognostic tool.
Therefore, the concepts of acceptance criteria, study data, ground truth, experts, and training/test sets as they relate to AI/ML device performance evaluation do not apply to this document.
The FDA clearance for TENS/EMS devices like this one is typically based on:
- Substantial Equivalence: Demonstrating that the new device is as safe and effective as a legally marketed predicate device. This often involves comparing technological characteristics (e.g., waveform, intensity, frequency, output modes) and performance data (e.g., electrical safety, electromagnetic compatibility, biocompatibility).
- Performance Testing: Benchtop testing to ensure the device meets its specifications and applicable IEC standards.
- Clinical Data (if necessary): In some cases, if the device has novel technology or a new indication, limited clinical data might be required, but it would focus on safety and effectiveness for pain relief (TENS) or muscle performance (EMS), not diagnostic accuracy or AI algorithm performance.
In summary, the information requested in your prompt (AI/ML-specific acceptance criteria, ground truth, expert review, training/test sets) is not present in this document because the device in question is a conventional electrical stimulator, not an AI/ML medical device.
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September 26, 2018
Everyway Medical Instruments Co., Ltd. Paul Hung Official Correspondent 3F1., No. 5, Lane 155, Section 3, Peishen Rd., Shenkeng District, New Taipei City, 22203 Tw
Re: K181707
Trade/Device Name: Everyway Wireless TENS & EMS Unit, Model EM-5200 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH, NGX Dated: June 26, 2018 Received: June 28, 2018
Dear Paul Hung:
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 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/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) K181707
Device Name
EM-5200 Wireless TENS & EMS Unit.
Indications for Use (Describe)
TENS: 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.
EMS: intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that the EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance. The EMS may therefore be considered a technique of muscle training.
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).