FDA device listing
Atos Medical The TheraBite® Jaw Motion Rehabilitation SystemTM
FDA device listing 1000389064 · Moldgenix LLC
Key facts
| Proprietary names | Atos Medical The TheraBite® Jaw Motion Rehabilitation SystemTM |
|---|---|
| Owner/operator | Moldgenix LLC |
| Owner/operator number | 10090559 |
| Product codes | ION |
| Device names | ION - Exerciser, Non-Measuring |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5370 |
| Review panels | Physical Medicine |
| Registered establishments | Moldgenix LLC |
| Establishment registrations | 2529596 |
| FEI numbers | 1000121324 |
| Establishment operations | Contract Manufacturer |
| 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