FDA device listing
Air Ankle Splint UNIVERSAL,Ankle Binder Air Pro (Black & Green/Black & Orange) S M L XL,Ankle Binder S/M/L,Ankle Binder…
FDA device listing 1160276824 · Tynor Orthotics (P) Ltd.
Key facts
| Proprietary names | Air Ankle Splint UNIVERSAL,Ankle Binder Air Pro (Black & Green/Black & Orange) S M L XL,Ankle Binder S/M/L,Ankle Binder Spl. Size XL,Ankle Binder Urbane S M L XL,Ankle Brace CH S M L,Ankle Brace Spl. Size XL,Ankle Splint UNIVERSAL,Ankle Stabilizer Kinezio S M L,Ankle Stabilizer Kinezio Spl. Size XL XXL,Ankle Stirrup with Air and Foam Bladders,Ankle Stirrup with Air and Foam Bladders. Size… |
|---|---|
| Owner/operator | Tynor Orthotics (P) Ltd. |
| Owner/operator number | 9070795 |
| Product codes | ITW |
| Device names | ITW - Joint, Ankle, External Brace |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | TYNOR ORTHOTICS (P) LTD. |
| Establishment registrations | 3005037196 |
| FEI numbers | 3005037196 |
| 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