FDA device listing
165 Neo G RX Wrist Brace (R/L) (Sizes S - L),309 Neo G Easy - Fit Wrist Brace (S - L),336 Neo G Easy-Fit Finger Splint…
FDA device listing 1420453239 · Variteks Ortopedi Sanayi A.S.
Key facts
| Proprietary names | 165 Neo G RX Wrist Brace (R/L) (Sizes S - L),309 Neo G Easy - Fit Wrist Brace (S - L),336 Neo G Easy-Fit Finger Splint (Sizes S - XL),350 Neo G Hand Rehabilitation Fist Shaped,396 Neo G Comfort/Relief Arthritis Gloves,458 Neo G Airflow Plus Elbow Support with Silicone (Sizes S - XL),560 Neo G Hand Rehab Therapy Ball - (3 Resistance levels: Red = Hard , Blue = Medium, Green = Soft ),721 Neo G… |
|---|---|
| Owner/operator | Variteks Ortopedi Sanayi A.S. |
| Owner/operator number | 10036107 |
| 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 | Variteks Ortopedi Sanayi A.S. |
| Establishment registrations | 3009303371 |
| FEI numbers | 3009303371 |
| Establishment operations | Contract Manufacturer, 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