FDA device listing
ComfoSmart,Foot-Ankle,Foot Drop Splint,Leaf Type
FDA device listing 1311395358 · Apothecaries Sundries Mfg Pvt Ltd
Key facts
| Proprietary names | ComfoSmart,Foot-Ankle,Foot Drop Splint,Leaf Type |
|---|---|
| Owner/operator | Apothecaries Sundries Mfg Pvt Ltd |
| Owner/operator number | 10026475 |
| Product codes | OHI |
| Device names | OHI - Orthosis, Foot Drop |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3475 |
| Review panels | Physical Medicine |
| Registered establishments | APOTHECARIES SUNDRIES MFG PVT LTD |
| Establishment registrations | 3007123908 |
| FEI numbers | 3007123908 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| 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