Danyang, CN · 5 510(k) clearances · 1 recalls (1 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| CAW | — | — | — | 2 | 2025-08-21 |
| JCX | Apparatus, Suction, Ward Use, Portable, Ac-Powered | Class II | General, Plastic Surgery | 1 | 2026-05-11 |
| ITI | Wheelchair, Powered | Class II | Physical Medicine | 1 | 2024-01-19 |
| IOR | Wheelchair, Mechanical | Class I | Physical Medicine | 1 | 2021-06-14 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2024-12-09 | Class I | Ongoing | Z-0795-2025 | JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L | — | Oxygen concentrator may melt or catch on fire during use. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-05-11 | K250964 | Protable Phlegm Suction Unit (JMA D01) | JCX | Class II | General, Plastic Surgery |
| 2025-08-21 | K251130 | Portable Oxygen Concentrator (JM-P50A) | CAW | — | — |
| 2024-01-19 | K232783 | Power wheelchair (Model: JMPW-01W) | ITI | Class II | Physical Medicine |
| 2023-11-09 | K230969 | Oxygen Concentrator | CAW | — | — |
| 2021-06-14 | K200466 | Manual Wheelchair (Model W28) | IOR | Class I | Physical Medicine |