FDA device listing
Iron weights for pulley weight system,SAEHAN Cast-Iron Weight Plate,SAEHAN Chest Pulley Weights,SAEHAN double handle…
FDA device listing 1373817737 · SAEHAN CORPORATION
Key facts
| Proprietary names | Iron weights for pulley weight system,SAEHAN Cast-Iron Weight Plate,SAEHAN Chest Pulley Weights,SAEHAN double handle weight system,SAEHAN Duplex Pulley Weights,SAEHAN Guide Rod for Pulley Weights, each,SAEHAN Metal Handle(Pair) for Pulley Weights,SAEHAN Single Column Duplex Pulley Weights,SAEHAN single pulley weight system,SAEHAN triple pulley weight system,SAEHAN Triplex Pulley Weights,SAEHAN… |
|---|---|
| Owner/operator | SAEHAN CORPORATION |
| Owner/operator number | 8040255 |
| Product codes | HST |
| Device names | HST - Apparatus, Traction, Non-Powered |
| Device class | Class I |
| Classification regulations (21 CFR) | 888.5850 |
| Review panels | Orthopedic |
| Registered establishments | SAEHAN CORPORATION |
| Establishment registrations | 8040255 |
| FEI numbers | 3010581156 |
| 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