FDA device listing
Air compression therapy systemFO3002,Air compression therapy systemFO3003,Air compression therapy systemFO3004,Air…
FDA device listing 1698989263 · FOFO medical co.,ltd
Key facts
| Proprietary names | Air compression therapy systemFO3002,Air compression therapy systemFO3003,Air compression therapy systemFO3004,Air compression therapy systemFO3005,Air compression therapy systemFO3006,Air compression therapy systemFO3007,Air compression therapy systemFO3009,Smart-DVT Air Compression Therapy System FO-3002mini |
|---|---|
| Owner/operator | FOFO medical co.,ltd |
| Owner/operator number | 10095802 |
| Premarket submissions | K212169 |
| Product codes | IRP |
| Device names | IRP - Massager, Powered Inflatable Tube |
| Device class | Class II |
| Classification regulations (21 CFR) | 890.5650 |
| Review panels | Physical Medicine |
| Registered establishments | FOFO MEDICAL CO.,LTD |
| Establishment registrations | 3045077467 |
| FEI numbers | 3045077467 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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