FDA device listing
ASO,ASO Speed Lacer,ASO With Stays,EVO,EVO Hinge,EVO Quatro Ankle Stabilizer,EVO Speed Lacer,EVO Speed Lacer Hinge,Flex…
FDA device listing 1689146402 · MEDICAL SPECIALTIES, INC.
Key facts
| Proprietary names | ASO,ASO Speed Lacer,ASO With Stays,EVO,EVO Hinge,EVO Quatro Ankle Stabilizer,EVO Speed Lacer,EVO Speed Lacer Hinge,Flex Hinge,PFO,Phantom Dorsal Night Splint,Supinator PTT Stabilizer,Vortex |
|---|---|
| Owner/operator | MEDICAL SPECIALTIES, INC. |
| Owner/operator number | 1016498 |
| Product codes | ITW |
| Device names | ITW - Joint, Ankle, External Brace |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | MEDICAL SPECIALTIES, INC. |
| Establishment registrations | 1016498 |
| FEI numbers | 1016498 |
| Establishment operations | 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