FDA device listing
Bed Rail,Bed Rails,KS-01001, KS-01012, KS-04005, KS-110004, KS-110013, KS-110016, KS-110018, KS-110027, KS-110027-2…
FDA device listing 1727548085 · Ksitex (Anhui) Great Health Industry Technology Co., Ltd.
Key facts
| Proprietary names | Bed Rail,Bed Rails,KS-01001, KS-01012, KS-04005, KS-110004, KS-110013, KS-110016, KS-110018, KS-110027, KS-110027-2, KS-110033, KS-110034,KS-110035,KS-110036,KS-110037, KS-110038,KS-110039,KS-110040,,KS-110041,KS-110042,KS-110043, KS-110044,KS-110045,KS-110046,,KS-110047,KS-110048,KS-110049, KS-110050,KS-110060, KS-110060A, KS-110060ACP, KS-110060CP, KS-110060G, KS-110060GA, KS-110060GACP… |
|---|---|
| Owner/operator | Ksitex (Anhui) Great Health Industry Technology Co., Ltd. |
| Owner/operator number | 10089509 |
| Product codes | QTC |
| Device names | QTC - Adult Portable Bed Rails For Medical Purposes |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.5050 |
| Review panels | Physical Medicine |
| Registered establishments | KSITEX (ANHUI) GREAT HEALTH INDUSTRY TECHNOLOGY CO., LTD. |
| Establishment registrations | 3030504647 |
| FEI numbers | 3030504647 |
| 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