(112 days)
The Pointer Plus is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain.
Not Found
I am sorry, but based on the provided text, there is no information available about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a US FDA 510(k) clearance letter for the "Pointer Plus" device (K060508). This letter confirms that the device has been found substantially equivalent to a legally marketed predicate device, allowing it to be marketed.
The content focuses on:
- The device name and regulatory information.
- The FDA's review and determination of substantial equivalence.
- General controls and regulations applicable to the device.
- Contact information for further guidance.
- Indications for Use: "The Pointer Plus is intended for use in the symptomatic relief of chronic intractable pain, postoperative pain, and acute pain."
The letter does not contain any performance data, clinical study results, acceptance criteria, or details regarding how the substantial equivalence was demonstrated in terms of device performance. These details would typically be found in the 510(k) submission itself, which is not provided here.
§ 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).