(240 days)
The C.C.Life 21 device with C-Life handle (RF) is indicated for the temporary relief of minor muscle aches and pain temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The C.C.Life 21 device with C-Life Micro handle (TENS) is intended for facial stimulation and is indicated for cosmetic use.
Not Found
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for the device "C.C. Life 21". It primarily focuses on regulatory compliance, outlining general controls, additional controls, and relevant regulations.
The document does not contain any information regarding:
- Acceptance criteria for device performance.
- The study that proves the device meets any acceptance criteria.
- Specific details about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for testing or training, or training set sizes/ground truth establishment.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.
§ 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).