(164 days)
TENS (Transcutaneous Electric Nerve Stimulation):
To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, abdomen, bottom, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.
EMS(Electrical Muscle Stimulation)/PMS (Powered Muscle Stimulation):
It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Not Found
I am sorry, but the provided text from the FDA 510(k) Clearance Letter for the "TENS AND EMS (TENS and Muscle Stimulator)" device (K243856) does not contain the detailed information necessary to answer your request regarding acceptance criteria and performance study data.
This 510(k) letter is a legal document from the FDA stating that the device has been found substantially equivalent to a legally marketed predicate device. It primarily covers administrative details such as:
- The device name and models
- The applicant's information
- Regulation numbers and product codes
- Regulatory classification (Class II)
- The date of clearance
- General controls provisions (registration, listing, GMP, labeling)
- Information about when new 510(k) submissions might be needed for device changes
- Requirements for Quality System (QS) regulation, UDI rule, and adverse event reporting
- Contact information for the FDA
Crucially, it does not include any technical details about the device's performance, clinical study results, acceptance criteria, or the methodology of studies (e.g., sample size, expert qualifications, ground truth establishment, MRMC studies, or standalone performance). This information would typically be found in the manufacturer's 510(k) submission, which is not publicly available in this FDA clearance letter.
Therefore, I cannot populate the table or provide answers to the specific questions you've asked based on the provided text.
§ 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).