FDA device listing
Finger orthosis,models of M01, M02, M03, M04, M05, M06, M07, M08, M09, M10, M11, M12, M13, M14, M15,Finger…
FDA device listing 1155404307 · Fortune Company Ltd.
Key facts
| Proprietary names | Finger orthosis,models of M01, M02, M03, M04, M05, M06, M07, M08, M09, M10, M11, M12, M13, M14, M15,Finger orthosis,models of M16, M17, M18, M19, M20, M21, M22, M23, M25, M26, M27, M28, M29, M30, M24,Hand orthosis, models of H01, H02, H03, H04, H05, H06, H07, HO8, H09, H10, H11, H12, H13, H14, H15, H16, H17, H18,Wristorthosis, Models of W01, W02, W03, W04, W05, W06, W07, W08, W09, W10, W11, W12… |
|---|---|
| Owner/operator | Fortune Company Ltd. |
| Owner/operator number | 10056738 |
| 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 | FORTUNE COMPANY LTD. |
| Establishment registrations | 3013198248 |
| FEI numbers | 3013198248 |
| Establishment operations | Contract Manufacturer, 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