JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD
FDA Regulatory Profile
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD appears in FDA public data with 1 recall — including 1 Class I (most serious) —, 5 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0795-2025, Class I) was initiated on December 9, 2024. Its most recent 510(k) clearance was granted on May 11, 2026.
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 5
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0795-2025 | Class I | JMC5A Ni/TruAire-5 Oxygen Concentrator, Model: O2C5L | December 9, 2024 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250964 | Protable Phlegm Suction Unit (JMA D01) | May 11, 2026 |
| K251130 | Portable Oxygen Concentrator (JM-P50A) | August 21, 2025 |
| K232783 | Power wheelchair (Model: JMPW-01W) | January 19, 2024 |
| K230969 | Oxygen Concentrator | November 9, 2023 |
| K200466 | Manual Wheelchair (Model W28) | June 14, 2021 |