FDA device listing

Instrument, Compression

FDA device listing 1568578807 · ARCH Medical Solutions - Seabrook

Key facts

Owner/operator ARCH Medical Solutions - Seabrook
Owner/operator number 1221763
Product codes HWN
Device names HWN - Instrument, Compression
Device class Class I
Classification regulations (21 CFR) 888.4540
Review panels Orthopedic
Registered establishments ARCH Medical Solutions - Seabrook
Establishment registrations 1221763
FEI numbers 1221763
Establishment operations Contract 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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