FDA device listing
Arm Sling Strap (UNIVERSAL),Carpal Tunnel Splint UNIVERSAL,Elastic Wrist Splint Right/Left S/M/L/XL,Finger Cot…
FDA device listing 1042608721 · Tynor Orthotics (P) Ltd.
Key facts
| Proprietary names | Arm Sling Strap (UNIVERSAL),Carpal Tunnel Splint UNIVERSAL,Elastic Wrist Splint Right/Left S/M/L/XL,Finger Cot S/M/L,Finger Ext. Splint S/M/L,Finger Sleeve,Forearm Splint UNIVERSAL,Frog Splint S/M/L,Glove Compression,Hand Resting Splint Right/Left CH/S/M/L,Lunar Splint UNIVERSAL,Mallet Finger Splint UNIVERSAL,Reversible Wrist Support UN,Solar Splint UNIVERSAL,Sweat Bands,Thumb Spica Splint… |
|---|---|
| Owner/operator | Tynor Orthotics (P) Ltd. |
| Owner/operator number | 9070795 |
| 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 | TYNOR ORTHOTICS (P) LTD. |
| Establishment registrations | 3005037196 |
| FEI numbers | 3005037196 |
| 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