FDA device listing

Care100 Bed,EasyCare Bed,Panacea 1000 - FLEX,Panacea 1750,Panacea 2000,RC Ultra Hi-Lo Bed,UCXT Bed,WeCare Home…

FDA device listing 1731685823 · JOERNS HEALTHCARE LLC

Key facts

Proprietary names Care100 Bed,EasyCare Bed,Panacea 1000 - FLEX,Panacea 1750,Panacea 2000,RC Ultra Hi-Lo Bed,UCXT Bed,WeCare Home Bed,WeCare Institutinal Bolted Frame,WeCare Institutional
Owner/operator JOERNS HEALTHCARE LLC
Owner/operator number 9105099
Product codes FNL
Device names FNL - Bed, Ac-Powered Adjustable Hospital
Device class Class II
Classification regulations (21 CFR) 880.5100
Review panels General Hospital
Registered establishments Joerns Healthcare, Joerns Healthcare Matamoros
Establishment registrations 3009402404, 3009525805, 3012392312
FEI numbers 3009402404, 3009525805, 3012392312
Establishment operations Complaint File Establishment, Specification Developer, Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None listed Premarket submission listed

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device listings

Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.

Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database

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