FDA device listing

Bruder,Dunlap,Soft Heat

FDA device listing 1883003501 · Kaz USA, Inc., A Helen of Troy Company

Key facts

Proprietary names Bruder,Dunlap,Soft Heat
Owner/operator Kaz USA, Inc., A Helen of Troy Company
Owner/operator number 1314800
Product codes IRT
Device names IRT - Pad, Heating, Powered
Device class Class II
Classification regulations (21 CFR) 890.5740
Review panels Physical Medicine
Registered establishments Helen of Troy Macao Limited, Kaz USA, Inc., A Helen of Troy Company
Establishment registrations 3004871905, 3006169981
FEI numbers 3004871905, 3006169981
Establishment operations Foreign Private Label Distributor, 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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