FDA device listing

CF HOT-COLD THERAPY 360 FREEZE SLEEVE,Copper Fit Pro Back With Hot & Cold Gel Pack,Copper Fit Rapid Relief Ankle,Copper…

FDA device listing 1942472077 · Ideavillage Products Corp.

Key facts

Proprietary names CF HOT-COLD THERAPY 360 FREEZE SLEEVE,Copper Fit Pro Back With Hot & Cold Gel Pack,Copper Fit Rapid Relief Ankle,Copper Fit Rapid Relief Back Wrap,Copper Fit Rapid Relief Elbow,Copper Fit Rapid Relief Knee,Copper Fit Rapid Relief Plantar Fascia,Copper Fit Rapid Relief Shoulder,Copper Fit Rapid Relief Wrist
Owner/operator Ideavillage Products Corp.
Owner/operator number 10031892
Product codes IME
Device names IME - Pack, Hot Or Cold, Reusable
Device class Class I
Classification regulations (21 CFR) 890.5700
Review panels Physical Medicine
Registered establishments IDEAVILLAGE PRODUCTS CORP.
Establishment registrations 2249769
FEI numbers 3003185120
Establishment operations Specification Developer
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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