FDA device listing
2D Dynamic Footrest Hanger,Foot Rests,Leg Rests,MAPS Footplate Mounting Hardware,MyOn Footrests,MyOn Legrests,Super…
FDA device listing 1198779685 · Invacare Corporation dba Invacare America
Key facts
| Proprietary names | 2D Dynamic Footrest Hanger,Foot Rests,Leg Rests,MAPS Footplate Mounting Hardware,MyOn Footrests,MyOn Legrests,Super Contracture Footrest Hanger |
|---|---|
| Owner/operator | Invacare Corporation dba Invacare America |
| Owner/operator number | 1525712 |
| Product codes | IMM |
| Device names | IMM - Footrest, Wheelchair |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3920 |
| Review panels | Physical Medicine |
| Registered establishments | FREEDOM DESIGNS, INC., INVACARE CORP. DBA INVACARE AMERICA, INVAMEX S.DE R.L. DE C.V. |
| Establishment registrations | 1531186, 2081283, 9616091 |
| FEI numbers | 2081283, 1000253203, 3002889431 |
| Establishment operations | Complaint File Establishment, Manufacturer, 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