FDA product code SGB: Pain Assessment Software In Non-Communicative Adults
SGB is the FDA product code for pain assessment software in non-communicative adults. It is a Class II device, regulated under 21 CFR 882.1472 and reviewed by the Neurology panel. Devices under SGB reach the market by 510(k); FDA lists no cleared 510(k)s for it. 1 De Novo request was granted under it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Pain Assessment Software In Non-Communicative Adults |
| Device class | Class II |
| Regulation | 21 CFR 882.1472 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
Recalls for SGB devices
openFDA lists no recalls for product code SGB.
Frequently asked questions
What is FDA product code SGB?
SGB is the FDA product code for pain assessment software in non-communicative adults. It is a Class II device, regulated under 21 CFR 882.1472 and reviewed by the Neurology panel.
What device class is SGB?
Class II, regulation 21 CFR 882.1472. Typical premarket route: 510(k).
Next steps
- Run an FDA pathway report with predicate devices for product code SGB
- Run a recall and safety report across every SGB manufacturer
- Watch product code SGB for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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