FDA device listing
TeleRange 2.0 Post-op Brace, Posterior Night Splint, ROM Universal Post-op Knee, Anchor Shoulder Brace,TeleRange Post-op…
FDA device listing 1433933947 · TOP SHELF MANUFACTURING, LLC
Key facts
| Proprietary names | TeleRange 2.0 Post-op Brace, Posterior Night Splint, ROM Universal Post-op Knee, Anchor Shoulder Brace,TeleRange Post-op Brace, TR Post-op Brace, TR Rapid Fit Post-op Brace, TR Rehab Post-op Brace, AB/EX Shoulder Strap,TR CC Post-op Knee, Over The Shoulder Humeral Fracture Brace, TR CC w/Covered Hinge, TSK Post-op Brace |
|---|---|
| Owner/operator | TOP SHELF MANUFACTURING, LLC |
| Owner/operator number | 9054233 |
| 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 | TOP SHELF MANUFACTURING, LLC |
| Establishment registrations | 3003890514 |
| FEI numbers | 3003890514 |
| 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