Pain Assessment Software In Non-Communicative Adults
SGB is the FDA product code for Pain Assessment Software In Non-Communicative Adults, a class II device type, regulated under 21 CFR 882.1472. FDA's definition for this code reads: "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 patient’s current level of pain in conscious adult patients who are unable to communicate their current pain level. This device is intended for...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- SGB
- Device name
- Pain Assessment Software In Non-Communicative Adults
- FDA 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 patient’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.
- Regulation
- 21 CFR 882.1472
- Device class
- Class II
- Review panel
- Neurology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code SGB
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2025 | 1 |
Applicants with the most clearances
Product code SGB| Applicant | Clearances |
|---|---|
| PainChek Ltd. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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