FDA device listing

Prosthetic Socks - CoolBlue,Suction and Locking Prosthetic Liners - Encore,Suction, Cushion, Locking Liners--WintersGel

FDA device listing 1249675129 · Symbiont Logistics, LLC

Key facts

Proprietary names Prosthetic Socks - CoolBlue,Suction and Locking Prosthetic Liners - Encore,Suction, Cushion, Locking Liners--WintersGel
Owner/operator Symbiont Logistics, LLC
Owner/operator number 1043591
Product codes ISS
Device names ISS - Prosthesis, Thigh Socket, External Component
Device class Class I
Classification regulations (21 CFR) 890.3420
Review panels Physical Medicine
Registered establishments SOUTHERN PROSTHETIC SUPPLY CO.
Establishment registrations 1043591
FEI numbers 1043591
Establishment operations 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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