FDA device listing
Bon Charge Infrared PEMF Mat Demi (Model: S-119),Bon Charge Infrared PEMF Mat Max (Model: S-120),Bon Charge Infrared…
FDA device listing 1497652057 · BLUblox Pty Ltd
Key facts
| Proprietary names | Bon Charge Infrared PEMF Mat Demi (Model: S-119),Bon Charge Infrared PEMF Mat Max (Model: S-120),Bon Charge Infrared PEMF Mat Mini (Model: S-118),Bon Charge Infrared PEMF Wrap (Model: S-117),Bon Charge Infrared Sauna Blanket (Model: S-102) |
|---|---|
| Owner/operator | BLUblox Pty Ltd |
| Owner/operator number | 10091860 |
| 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 | BLUBLOX PTY LTD |
| Establishment registrations | 3033590685 |
| FEI numbers | 3033590685 |
| 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