(140 days)
TENS: The device is designed 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. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
Not Found
I am sorry, but the provided text does not contain any information about acceptance criteria or a study that proves a device meets those criteria. The document is an FDA 510(k) clearance letter for an EMS/TENS Massager Device, indicating it has been found substantially equivalent to a predicate device.
It details:
- The device name and regulatory information.
- The date of the review and clearance.
- General controls and additional regulations applicable to the device.
- Instructions on when a new 510(k) might be required for changes.
- Information about quality system regulations and reporting adverse events.
- The Indications for Use for the TENS (pain relief) and EMS (muscle performance) functions.
- Confirmation that it is for Over-The-Counter Use.
There is no mention of:
- Specific performance metrics or acceptance criteria for the device's functions (e.g., pain reduction levels, muscle strength improvement percentages).
- Any studies (clinical or performance) conducted to demonstrate the device meets any such criteria.
- Sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment.
Therefore, I cannot fulfill your request for the detailed table and study information 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).