FDA device listing
164 Neo G RX Ankle Support (Sizes S - XL),456 Neo G Airflow Plus Ankle Support with Silicone (Sizes S - XL),474 Neo G…
FDA device listing 1769089221 · Variteks Ortopedi Sanayi A.S.
Key facts
| Proprietary names | 164 Neo G RX Ankle Support (Sizes S - XL),456 Neo G Airflow Plus Ankle Support with Silicone (Sizes S - XL),474 Neo G Plantar Fasciitis Everyday Support (Sizes S - XL),724 Neo G Airflow Ankle Support (Sizes S - XL),762 NEO G ACTIVE PLUS ACHILLES TENDON SUPPORT,814 Neo G Ankle Brace with Air Pads,815 Neo G Ankle Brace with Sponge Pads,816 Neo G Ankle Brace with Gel Pads,854 Neo G Laced Ankle Brace… |
|---|---|
| Owner/operator | Variteks Ortopedi Sanayi A.S. |
| Owner/operator number | 10036107 |
| 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 | Variteks Ortopedi Sanayi A.S. |
| Establishment registrations | 3009303371 |
| FEI numbers | 3009303371 |
| Establishment operations | Foreign Exporter, 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