(301 days)
The MAX-IF1000 interferential stimulator is used for symptomatic relief and management of chronic pain and/or an adjunctive treatment in the management of postsurgical and posttraumatic acute pain.
MAX-IF1000 Interferential Stimulator
The provided text is a US FDA 510(k) clearance letter for the MAX-IF1000 Interferential Stimulator. It does not contain any information about acceptance criteria, device performance metrics, study designs, sample sizes, ground truth establishment, or expert qualifications.
The letter primarily:
- Identifies the device and applicant.
- States that the device has been found substantially equivalent to a legally marketed predicate device.
- Outlines general regulatory requirements for marketed devices (e.g., registration, labeling, good manufacturing practice).
- Provides contact information for various FDA divisions.
- Includes an "Indications for Use" statement for the device.
Therefore, I cannot provide the requested information based on the input text. The text is a regulatory clearance document, not a scientific study report or clinical trial summary.
To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness data, a clinical study report, or the relevant sections from a 510(k) submission that details 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).