FDA device listing
BLUEPOINT 3/4LENGTH GEL INSOLES SIZE 2-5,BLUEPOINT 3/4LENGTH GEL INSOLES SIZE 6-8,BLUEPOINT 3/4LENGTH GEL INSOLES SIZE…
FDA device listing 1355026844 · POLYGEL LLC.
Key facts
| Proprietary names | BLUEPOINT 3/4LENGTH GEL INSOLES SIZE 2-5,BLUEPOINT 3/4LENGTH GEL INSOLES SIZE 6-8,BLUEPOINT 3/4LENGTH GEL INSOLES SIZE 9+,BLUEPOINT FULL LENGTH GEL INSOLES SIZE 10+,BLUEPOINT FULL LENGTH GEL INSOLES SIZE 3-4,BLUEPOINT FULL LENGTH GEL INSOLES SIZE 4-5,BLUEPOINT FULL LENGTH GEL INSOLES SIZE 6-7,BLUEPOINT FULL LENGTH GEL INSOLES SIZE 7-8,BLUEPOINT FULL LENGTH GEL INSOLES SIZE 9-10 |
|---|---|
| Owner/operator | POLYGEL LLC. |
| Owner/operator number | 9080190 |
| Product codes | KYS |
| Device names | KYS - Insoles, Medical |
| Device class | Class I |
| Classification regulations (21 CFR) | 880.6280 |
| Review panels | General Hospital |
| Registered establishments | POLYGEL LLC. |
| Establishment registrations | 3005621376 |
| FEI numbers | 3005621376 |
| Establishment operations | Specification Developer |
| 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