FDA device listing
Axiom AS,Axiom ASP,Axiom G,Axiom G with Incontinent Cover,Axiom One,Axiom P,Axiom P with Incontinent Cover,Axiom…
FDA device listing 1674087405 · Ki Mobility
Key facts
| Proprietary names | Axiom AS,Axiom ASP,Axiom G,Axiom G with Incontinent Cover,Axiom One,Axiom P,Axiom P with Incontinent Cover,Axiom PXP,Axiom PXP with Incontinent Cover,Axiom PXSP,Axiom PXSP with Incontinent Cover,Axiom S,Axiom SPF,Axiom SPF with Incontinent Cover,Axiom SPV,Axiom SPV with Incontinent Cover,Axiom S with Incontinent Cover |
|---|---|
| Owner/operator | Ki Mobility |
| Owner/operator number | 10023866 |
| Product codes | IMP |
| Device names | IMP - Cushion, Wheelchair |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3920 |
| Review panels | Physical Medicine |
| Registered establishments | Ki Mobility |
| Establishment registrations | 3005905321 |
| FEI numbers | 3005905321 |
| Establishment operations | Manufacturer, 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