FDA device listing
AD1 Wireless Adaptor,DG1 Wireless Dongle,E-LINK DFP2,E-LINK DFP4,E-LINK E4000 UPPER LIMB EXERCISER,E-LINk EP10…
FDA device listing 1062774675 · BIOMETRICS LTD
Key facts
| Proprietary names | AD1 Wireless Adaptor,DG1 Wireless Dongle,E-LINK DFP2,E-LINK DFP4,E-LINK E4000 UPPER LIMB EXERCISER,E-LINk EP10 Evaluation and Exercise Package,E-LINK EP11 Upper Extremity Evaluation and Exercise Package,E-LINK EP12 Exercise Package,E-LINK EP20 Exercise and Evaluation Package,E-LINK EP21 Upper Extremity Evaluation and Exercise Package,E-LINK EP24 Exercise Package,E-LINK EP40 Dual Acis ForcePlate… |
|---|---|
| Owner/operator | BIOMETRICS LTD |
| Owner/operator number | 8021957 |
| Premarket submissions | K962855 |
| Product codes | ISD |
| Device names | ISD - Exerciser, Measuring |
| Device class | Class II |
| Classification regulations (21 CFR) | 890.5360 |
| Review panels | Physical Medicine |
| Registered establishments | BIOMETRICS LTD. |
| Establishment registrations | 8021957 |
| FEI numbers | 3768 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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