SGB — Pain Assessment Software In Non-Communicative Adults Class II
FDA product code SGB covers "Pain Assessment Software In Non-Communicative Adults", a Class II medical device regulated under 21 CFR 882.1472. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SGB
- Device Class
- Class II
- Regulation Number
- 882.1472
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
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 patients 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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240073 | Painchek Limited (Ltd.) | PainChek (PainChek Adult) | Oct 6, 2025 |