510(k) K250964
K250964 is an FDA 510(k) premarket notification submitted by Jiangsu Jumao X-Care Medical Equipment Co., Ltd. for the device "Protable Phlegm Suction Unit (JMA D01)". The FDA issued a decision of Substantially Equivalent on May 11, 2026. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Jiangsu Jumao X-Care Medical Equipment Co., Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 2026
- Date Received
- March 31, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type