FDA device listing

Air Compression Therapy Device MF-AWI, Leg Massager,Air Compression Therapy Recovery System MF-AWI, Air Pressure…

FDA device listing 1075483214 · Jiangsu MaxF Electric Appliance Co.,Ltd

Key facts

Proprietary names Air Compression Therapy Device MF-AWI, Leg Massager,Air Compression Therapy Recovery System MF-AWI, Air Pressure Massager.
Owner/operator Jiangsu MaxF Electric Appliance Co.,Ltd
Owner/operator number 10068621
Premarket submissions K230500
Product codes IRP
Device names IRP - Massager, Powered Inflatable Tube
Device class Class II
Classification regulations (21 CFR) 890.5650
Review panels Physical Medicine
Registered establishments JIANGSU MAXF ELECTRIC APPLIANCE CO.,LTD
Establishment registrations 3017153262
FEI numbers 3017153262
Establishment operations Foreign Exporter, Manufacturer
Registration valid through 2026

At a glance

  • 1–9 Registered establishments listing this device
  • None UDI devices (GUDID) under the same submission
  • 1–9 Device listings citing the same submission
  • Yes 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

Browse all FDA device listings