FDA device listing

Headache Cap

FDA device listing 1277372147 · Arlington Specialties, Inc.

Key facts

Proprietary names Headache Cap
Owner/operator Arlington Specialties, Inc.
Owner/operator number 10047238
Product codes KYR
Device names KYR - Bag, Ice
Device class Class I
Classification regulations (21 CFR) 880.6050
Review panels General Hospital
Registered establishments ARLINGTON SPECIALTIES, INC.
Establishment registrations 3011050481
FEI numbers 3011050481
Establishment operations Complaint File Establishment, Repackager/Relabeler
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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