# Fofo Medical Co.,Ltd (foreign exporter, Xiamen Fujian, CN): 1 new FDA device listing, incl. pack, hot or cold, water circulating

**Score:** 40/100

| Field | Value |
|---|---|
| Establishment | Fofo Medical Co.,Ltd |
| Owner / operator | FOFO medical co.,ltd |
| Role | Foreign exporter |
| Establishment types | Export Device to the United States But Perform No Other Operation on Device |
| Location | Xiamen Fujian, CN |
| New listings | 1 |
| Devices | Pack, Hot Or Cold, Water Circulating |
| Product codes | ILO |
| Device classes | Class II |
| Medical specialties | Physical Medicine |
| Brand names | Cold Therapy System |
| First new listing | 2026-07-24 |
| Latest new listing | 2026-07-24 |
| FDA registration number | 3045077467 |
| Registration expires | 2026-12-31 |

## Why this score
- Class II or III devices: QMS and regulatory demands.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.