FDA device listing
M-Finger,M-Thumb,Partial M-Finger,Titan Full locking finger,Titan partial locking finger,Titan thumb
FDA device listing 1589434859 · Partial Hand Solutions
Key facts
| Proprietary names | M-Finger,M-Thumb,Partial M-Finger,Titan Full locking finger,Titan partial locking finger,Titan thumb |
|---|---|
| Owner/operator | Partial Hand Solutions |
| Owner/operator number | 10052245 |
| Product codes | IRA |
| Device names | IRA - Hand, External Limb Component, Mechanical |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3420 |
| Review panels | Physical Medicine |
| Registered establishments | PARTIAL HAND SOLUTIONS, LLC |
| Establishment registrations | 3012687001 |
| FEI numbers | 3012687001 |
| 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