FDA device listing

Backrest brace Cross,Calf strap Cross/Next,Calf support,Comfort wedge,Cover armrest,Headrest bracket,Heel strap…

FDA device listing 1386032365 · Etac Supply Center AB

Key facts

Proprietary names Backrest brace Cross,Calf strap Cross/Next,Calf support,Comfort wedge,Cover armrest,Headrest bracket,Heel strap footrest,Mudguard,Push handle height adj,Seat cushion universal,Spoke guard
Owner/operator Etac Supply Center AB
Owner/operator number 10037519
Product codes KNO
Device names KNO - Accessories, Wheelchair
Device class Class I
Classification regulations (21 CFR) 890.3910
Review panels Physical Medicine
Registered establishments ETAC SUPPLY CENTER AB
Establishment registrations 3008986539
FEI numbers 3008986539
Establishment operations 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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