(286 days)
This device is intended to be used for physiological monitoring, biofeedback training, incontinence, relaxation training, muscle reeducation and research.
Physiological Monitoring & Biofeedback Instrument
I apologize, but the provided text from the FDA 510(k) clearance letter for the "J&L I-410 Physiological Monitoring & Biofeedback Instrument" (K971708) does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The document is a standard FDA clearance letter, which states that the device is "substantially equivalent" to predicate devices and can therefore be marketed. It outlines regulatory requirements and provides contact information. It does not include technical specifications, performance metrics, or details of any studies conducted to validate the device's performance against specific acceptance criteria.
Therefore, I cannot provide the requested information in the table or answer the subsequent questions based on the provided text.
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.