Product code SGB
- Device name
- Pain Assessment Software In Non-Communicative Adults
- Medical specialty
- Neurology
- Device class
- 2
- Regulation number
- 882.1472
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Pain assessment software in non-communicative adults is a prescription-only device that combines information from clinical pain domains to produce an output indicative of a patientÂ’s current level of pain in conscious adult patients who are unable to communicate their current pain level. This device is intended for adjunctive use and not intended as a stand-alone diagnostic or prognostic tool.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records
| 510(k) | Device | Applicant | Decision date |
|---|
| DEN240073 | PainChek (PainChek Adult) | Painchek Limited (Ltd.) | 2025-10-06 |