FDA device listing

Walker, Mechanical

FDA device listing 1745627871 · MBL (Xiamen) Co. Ltd

Key facts

Owner/operator MBL (Xiamen) Co. Ltd
Owner/operator number 10059383
Product codes ITJ
Device names ITJ - Walker, Mechanical
Device class Class I
Classification regulations (21 CFR) 890.3825
Review panels Physical Medicine
Registered establishments MBL (XIAMEN) CO. LTD
Establishment registrations 3006774806
FEI numbers 3006774806
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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