FDA device listing

Bicycle-Ergometer h/p/cosmos torqualizer,Ergometer (bicycle),h/p/cosmos,Torqualizer

FDA device listing 1509781753 · H/P/COSMOS SPORTS & MEDICAL GMBH

Key facts

Proprietary names Bicycle-Ergometer h/p/cosmos torqualizer,Ergometer (bicycle),h/p/cosmos,Torqualizer
Owner/operator H/P/COSMOS SPORTS & MEDICAL GMBH
Owner/operator number 9043040
Product codes ISD
Device names ISD - Exerciser, Measuring
Device class Class II
Classification regulations (21 CFR) 890.5360
Review panels Physical Medicine
Registered establishments H/P/COSMOS SPORTS & MEDICAL GMBH
Establishment registrations 3008309560
FEI numbers 3008309560
Establishment operations Contract Manufacturer, Foreign Exporter, Manufacturer, Remanufacturer, Repackager/Relabeler, 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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