FDA device listing
DS2 Insole
FDA device listing 1771930583 · Summit Labs LLC
Key facts
| Proprietary names | DS2 Insole |
|---|---|
| Owner/operator | Summit Labs LLC |
| Owner/operator number | 10051661 |
| Product codes | KNP |
| Device names | KNP - Orthosis, Corrective Shoe |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | SUMMIT LABS LLC |
| Establishment registrations | 3012544667 |
| FEI numbers | 3012544667 |
| 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