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Parker Quality & Compliance

PQC Reg Watch

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Device type

Powered Fecal Management System

Product code SJB · Class II · 21 CFR 876.5230 · Gastroenterology, Urology

A powered fecal management system is a device that uses powered components to partially or fully divert and contain fecal waste away from a bed-ridden patient. This classification includes accessories such as filters, conduits for fecal waste transfer, and receptacles for fecal waste containment.

FDA classification database

Recent 510(k)s

Recent recalls

No recalls in the archive for SJB.