FDA device listing
TiLite Aero T,TiLite Aero Z,TiLite CR1,TiLite TR,TiLite TRA,TiLite Twist,TiLite Z,TiLite ZR,TiLite ZRA
FDA device listing 1529543331 · TISPORT, LLC
Key facts
| Proprietary names | TiLite Aero T,TiLite Aero Z,TiLite CR1,TiLite TR,TiLite TRA,TiLite Twist,TiLite Z,TiLite ZR,TiLite ZRA |
|---|---|
| Owner/operator | TISPORT, LLC |
| Owner/operator number | 9036395 |
| Premarket submissions | K990358 |
| Product codes | IOR |
| Device names | IOR - Wheelchair, Mechanical |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3850 |
| Review panels | Physical Medicine |
| Registered establishments | TISPORT, LLC |
| Establishment registrations | 3032618 |
| FEI numbers | 3002653226 |
| Establishment operations | Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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