FDA device listing

COLD / HOT PAD

FDA device listing 1693771456 · FOURSTAR GROUP INC.

Key facts

Proprietary names COLD / HOT PAD
Owner/operator FOURSTAR GROUP INC.
Owner/operator number 8043323
Product codes IMD
Device names IMD - Pack, Hot Or Cold, Disposable
Device class Class I
Classification regulations (21 CFR) 890.5710
Review panels Physical Medicine
Registered establishments Fourstar Group, FOURSTAR GROUP INC.
Establishment registrations 8043323, 3007838093
FEI numbers 3006078362, 3007838093
Establishment operations Foreign Exporter
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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