FDA device listing
Air pressure suit:ZK-A01,ZK-A02,ZK-A03,ZK-A04,ZK-A05,ZK-A06,ZK-A07,ZK-A08,ZK-A09,ZK-A10,ZK-A11,ZK-A12,ZK-A13,,ZK-A14,ZK…
FDA device listing 1788298516 · Foshan Zike Technology Co., Ltd.
Key facts
| Proprietary names | Air pressure suit:ZK-A01,ZK-A02,ZK-A03,ZK-A04,ZK-A05,ZK-A06,ZK-A07,ZK-A08,ZK-A09,ZK-A10,ZK-A11,ZK-A12,ZK-A13,,ZK-A14,ZK-A15,ZK-A16,ZK-A17,ZK-A18,ZK-A19,ZK-A20 |
|---|---|
| Owner/operator | Foshan Zike Technology Co., Ltd. |
| Owner/operator number | 10094939 |
| Product codes | ECB |
| Device names | ECB - Unit, Syringe, Air And/Or Water |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.4565 |
| Review panels | Dental |
| Registered establishments | FOSHAN ZIKE TECHNOLOGY CO., LTD. |
| Establishment registrations | 3040278125 |
| FEI numbers | 3040278125 |
| 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