FDA device listing
Mand.ro Mark 5,Mand.ro Mark 7,Mand.ro Mark 7A,Mand.ro Mark 7B,Mand.ro Mark 7D,Mand.ro Mark 7X
FDA device listing 1051585759 · Mand.ro Co., Ltd.
Key facts
| Proprietary names | Mand.ro Mark 5,Mand.ro Mark 7,Mand.ro Mark 7A,Mand.ro Mark 7B,Mand.ro Mark 7D,Mand.ro Mark 7X |
|---|---|
| Owner/operator | Mand.ro Co., Ltd. |
| Owner/operator number | 10094346 |
| Product codes | IQZ |
| Device names | IQZ - Hand, External Limb Component, Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3420 |
| Review panels | Physical Medicine |
| Registered establishments | Mand.ro Co., Ltd. |
| Establishment registrations | 3042204925 |
| FEI numbers | 3042204925 |
| 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