FDA device listing
Toto Automated Lateral Turning System
FDA device listing 1835664086 · Frontier Therapeutics Inc.
Key facts
| Proprietary names | Toto Automated Lateral Turning System |
|---|---|
| Owner/operator | Frontier Therapeutics Inc. |
| Owner/operator number | 10059719 |
| Product codes | IKZ |
| Device names | IKZ - Bed, Patient Rotation, Powered |
| Device class | Class II |
| Classification regulations (21 CFR) | 890.5225 |
| Review panels | Physical Medicine |
| Registered establishments | FRONTIER THERAPEUTICS INC. |
| Establishment registrations | 3015423385 |
| FEI numbers | 3015423385 |
| Establishment operations | Complaint File Establishment |
| 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