FDA device listing
Apollo Wrist Brace,Classic Wrist Brace,Contender Brace,Elasto-Fit Wrist Support,FastForm SCB Hand-based thumb Spica…
FDA device listing 1083941247 · Breg Inc
Key facts
| Proprietary names | Apollo Wrist Brace,Classic Wrist Brace,Contender Brace,Elasto-Fit Wrist Support,FastForm SCB Hand-based thumb Spica Orthosis,FastForm SCB Hook & Loop refresh Strips,FastForm SCB Immobilizer,FastForm SCB Short Arm Multifunctional Orthosis,FastForm SCB Tension Straps,FastForm SCB Thumb Spica Multifunctional Orthosis,FastForm SCB Universal Gutter Multifunctional Orthosis,FastForm SCB VERSI… |
|---|---|
| Owner/operator | Breg Inc |
| Owner/operator number | 10041297 |
| Product codes | ILH |
| Device names | ILH - Splint, Hand, And Components |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | BREG, INC., BREG, INC.,, BREG MEXICO, S. DE R.L. DE C.V. (3), BREG MEXICO, S. DE R.L. DE C.V. (4) |
| Establishment registrations | 2028253, 3010694026, 3015960622, 3027500264 |
| FEI numbers | 1000125378, 3010694026, 3015960622, 3027500264 |
| Establishment operations | Manufacturer, Repackager/Relabeler, 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