FDA device listing

APEX MOIST HEAT PACK,Core Clover Pack,Micro Bead Eye Compress,MICROBEAD MOIST HEAT THERAPY MITT,Micro Bead Pack,Moist…

FDA device listing 1766395910 · Core Products International, Inc.

Key facts

Proprietary names APEX MOIST HEAT PACK,Core Clover Pack,Micro Bead Eye Compress,MICROBEAD MOIST HEAT THERAPY MITT,Micro Bead Pack,Moist Heat pack,Swede-O Joint Wrap,ThermalCore Moist Heat Packs
Owner/operator Core Products International, Inc.
Owner/operator number 9002815
Product codes IMA
Device names IMA - Pack, Heat, Moist
Device class Class I
Classification regulations (21 CFR) 890.5730
Review panels Physical Medicine
Registered establishments Core Products International Inc
Establishment registrations 3008008970
FEI numbers 3008008970
Establishment operations 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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