FDA device listing
441R-BS-L MCDAVID Level 1 Calf Sleeve - Black - Large,441R-BS-M MCDAVID Level 1 Calf Sleeve - Black - Medium,441R-BS-S…
FDA device listing 1153136737 · CR UNO Industrial Co. LTD
Key facts
| Proprietary names | 441R-BS-L MCDAVID Level 1 Calf Sleeve - Black - Large,441R-BS-M MCDAVID Level 1 Calf Sleeve - Black - Medium,441R-BS-S MCDAVID Level 1 Calf Sleeve - Black - Small,441R-BS-XL MCDAVID Level 1 Calf Sleeve - Black - XL,442R MCDAVID Level 2 Shin Splint Support / adjustable - Black - One Size,471R-BS-L MCDAVID Level 1 Thigh Sleeve - Black - Large,471R-BS-M MCDAVID Level 1 Thigh Sleeve - Black… |
|---|---|
| Owner/operator | CR UNO Industrial Co. LTD |
| Owner/operator number | 10033413 |
| Product codes | IQI |
| Device names | IQI - Orthosis, Limb Brace |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | CR UNO INDUSTRIAL CO. LTD |
| Establishment registrations | 3008520652 |
| FEI numbers | 3008520652 |
| Establishment operations | Contract Manufacturer, 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