FDA device listing
AND COMPONENTS,SELECTION,S.O.T,Vission,WRIST SPLINTS
FDA device listing 1107489164 · Allard Support for Better Life AB
Key facts
| Proprietary names | AND COMPONENTS,SELECTION,S.O.T,Vission,WRIST SPLINTS |
|---|---|
| Owner/operator | Allard Support for Better Life AB |
| Owner/operator number | 8030901 |
| Product codes | ILH |
| Device names | ILH - Splint, Hand, And Components |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | ALLARD USA INC., CAMP SCANDINAVIA AB |
| Establishment registrations | 8030901, 3005282622 |
| FEI numbers | 3005150907, 3005282622 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, 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