FDA device listing
BE105, BE405, BE150, L01, L02, L03, L04, L05, L06, D01, D02, D03, D04, D05, D06, BE400, BE700, BE400, BE700, PC01…
FDA device listing 1627219380 · Sungrow Technology Co.,Limited
Key facts
| Proprietary names | BE105, BE405, BE150, L01, L02, L03, L04, L05, L06, D01, D02, D03, D04, D05, D06, BE400, BE700, BE400, BE700, PC01, PC02,,Belt, Red Light Belt, LED Red Light Belt, LED Light Mat: (BE-G122, BE-G66, BE-G56, BE-G80, G56, BE120, BE120P, BE105P,,Pad, Mat, PEMF Mat, Heating Mat: (PE01, PE02, PE03, PE04),PC03, PC04); |
|---|---|
| Owner/operator | Sungrow Technology Co.,Limited |
| Owner/operator number | 10091832 |
| Product codes | IRT |
| Device names | IRT - Pad, Heating, Powered |
| Device class | Class II |
| Classification regulations (21 CFR) | 890.5740 |
| Review panels | Physical Medicine |
| Registered establishments | SUNGROW TECHNOLOGY CO.,LIMITED |
| Establishment registrations | 3033883954 |
| FEI numbers | 3033883954 |
| Establishment operations | Foreign Exporter, 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