FDA device listing

Care Max, Knee Care Device,Lumbar Lift Back Stretcher

FDA device listing 1029522877 · JIANGSU ALPHAY INTERNATIONAL TRADE CO., LTD.

Key facts

Proprietary names Care Max, Knee Care Device,Lumbar Lift Back Stretcher
Owner/operator JIANGSU ALPHAY INTERNATIONAL TRADE CO., LTD.
Owner/operator number 10023966
Product codes IRT
Device names IRT - Pad, Heating, Powered
Device class Class II
Classification regulations (21 CFR) 890.5740
Review panels Physical Medicine
Registered establishments JIANGSU ALPHAY MEDICAL DEVICE CO., LTD.
Establishment registrations 3006891384
FEI numbers 3006891384
Establishment operations Contract Manufacturer, Foreign Exporter, 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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