FDA device listing
PHOCUS-PRO,PHOCUS-ULTRA,POLY Pro Regen,POLY Pro ULTRA Regen
FDA device listing 1398786310 · XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD
Key facts
| Proprietary names | PHOCUS-PRO,PHOCUS-ULTRA,POLY Pro Regen,POLY Pro ULTRA Regen |
|---|---|
| Owner/operator | XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD |
| Owner/operator number | 10046889 |
| Product codes | ILY |
| Device names | ILY - Lamp, Infrared, Therapeutic Heating |
| Device class | Class II |
| Classification regulations (21 CFR) | 890.5500 |
| Review panels | Physical Medicine |
| Registered establishments | XUZHOU KERNEL MEDICAL EQUIPMENT CO LTD |
| Establishment registrations | 3008393409 |
| FEI numbers | 3008393409 |
| Establishment operations | Contract 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