FDA device listing

braceUP

FDA device listing 1192887167 · JIANGSU XIANGYU FITNESS EQUIPMENT CO., LTD.

Key facts

Proprietary names braceUP
Owner/operator JIANGSU XIANGYU FITNESS EQUIPMENT CO., LTD.
Owner/operator number 10078833
Product codes KTD
Device names KTD - Orthosis, Abdominal
Device class Class I
Classification regulations (21 CFR) 890.3490
Review panels Physical Medicine
Registered establishments JIANGSU XIANGYU FITNESS EQUIPMENT CO., LTD.
Establishment registrations 3017621989
FEI numbers 3017621989
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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