(105 days)
The DT-600 is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (EMSamond transcutaneous electrical nerve stimulation (TENS).
As a EMS device, DT-600 is indicated for the following conditions:
-
· Relaxation of muscle spasms
As a TENS device, the DT-600 is indicated for the following conditions: -
· For symptomatic relief of chronic intractable pain.
The DT-600 is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (EMSamond transcutaneous electrical nerve stimulation (TENS).
The provided document is a 510(k) clearance letter from the FDA for a device named DT-600. It asserts substantial equivalence to a predicate device and outlines the indications for use. However, this document does not contain any information regarding specific acceptance criteria, study data, sample sizes, expert qualifications, or details about comparative effectiveness studies (MRMC or standalone).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using only the provided text. The document is solely a regulatory clearance letter, not a study report or clinical trial summary.
To answer your questions, I would need additional documentation such as:
- A clinical study report
- A summary of safety and effectiveness (SSE) or a substantial equivalence submission (510(k) summary) that would typically accompany such a clearance letter and include details about performance testing.
§ 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).