FDA device listing
Lumo Clamp, STD,Lumo Cuff, STD-MED-A,Lumo Cuff, STD-MED-B,Lumo Cuff, STD-MED-C,Lumo Cuff, STD-MED-D,Lumo Cuff…
FDA device listing 1487928241 · macu4 GmbH
Key facts
| Proprietary names | Lumo Clamp, STD,Lumo Cuff, STD-MED-A,Lumo Cuff, STD-MED-B,Lumo Cuff, STD-MED-C,Lumo Cuff, STD-MED-D,Lumo Cuff, STD-MED-E,Lumo Cuff, STD-SML-A,Lumo Cuff, STD-SML-B,Lumo Cuff, STD-SML-C,Lumo Cuff, STD-SML-D,Lumo Cuff, STD-SML-E,Lumo Hold, Lock,Lumo Roll, STD,Lumo Shovel, STD,Lynk Clic Adapter,Lynk Clic Head 0°,Lynk Clic Head 360°,Lynk Clic Head 70°,Lynk Clic Lock Adapter,Lynk Clic Lock Head 0°… |
|---|---|
| Owner/operator | macu4 GmbH |
| Owner/operator number | 10094184 |
| Product codes | ILT |
| Device names | ILT - Adaptor, Recreational |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5050 |
| Review panels | Physical Medicine |
| Registered establishments | macu4 GmbH |
| Establishment registrations | 3042101018 |
| FEI numbers | 3042101018 |
| 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