(187 days)
Interferential Stimulation is used for symptomatic relief and management of chronic pain and/or intractable pain and as an adjunct in the management of post-surgical and post-traumatic acute pain.
Interferential Stimulator Model BMLS02-6
This is an FDA 510(k) clearance letter for an Interferential Stimulator, Model BMLS02-6. This type of document does not contain the detailed study information or acceptance criteria you are requesting.
FDA clearance letters typically:
- State that the device has been found substantially equivalent to a predicate device.
- List the device name, regulation number, and product code.
- Specify the indications for use.
- Refer to general controls and applicable regulations.
They do not include:
- Specific acceptance criteria for performance.
- Results of studies proving the device meets those criteria (e.g., performance tables, sample sizes, expert qualifications, ground truth methods, MRMC studies, standalone performance).
- Details about training sets or how their ground truth was established.
To find the information you are looking for, you would typically need to consult the full 510(k) summary, clinical study reports, or other design control documents submitted to the FDA, which are generally not part of the publicly released clearance letter.
§ 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).