FDA device listing

Humilty Precision Temperature Management System

FDA device listing 1799536754 · Humanity Life Extension, LLC

Key facts

Proprietary names Humilty Precision Temperature Management System
Owner/operator Humanity Life Extension, LLC
Owner/operator number 10092403
Product codes DWJ
Device names DWJ - System, Thermal Regulating
Device class Class II
Classification regulations (21 CFR) 870.5900
Review panels Cardiovascular
Registered establishments HUMANITY LIFE EXTENSION, LLC
Establishment registrations 3035108304
FEI numbers 3035108304
Establishment operations U.S. Manufacturer of Export Only Devices
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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