FDA device listing
Head Guard; Neck Guard
FDA device listing 1007710206 · GUARDMED HEALTHCARE KH CO., LTD.
Key facts
| Proprietary names | Head Guard; Neck Guard |
|---|---|
| Owner/operator | GUARDMED HEALTHCARE KH CO., LTD. |
| Owner/operator number | 10094272 |
| Product codes | NDA |
| Device names | NDA - Helmet, Cranial, For Protective Use |
| Device class | Class I |
| Classification regulations (21 CFR) | 890.3025 |
| Review panels | Physical Medicine |
| Registered establishments | GUARDMED HEALTHCARE KH CO., LTD. |
| Establishment registrations | 3042251637 |
| FEI numbers | 3042251637 |
| Establishment operations | Foreign Exporter |
| 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