Pain Assessment Software In Non-Communicative Adults

SGB · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.1472

Classification

FDA Product Code: SGB
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 882.1472
Review panel: NE
Medical specialty: Neurology
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown