510(k) K253076
K253076 is an FDA 510(k) premarket notification submitted by Chengdu Cryo-Push Medical Technology Co.,Ltd for the device "Cryopush Cold Compression Device (A02-P-001)". The FDA issued a decision of Substantially Equivalent on April 2, 2026. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Chengdu Cryo-Push Medical Technology Co.,Ltd has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 2, 2026
- Date Received
- September 23, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Powered Inflatable Tube
- Device Class
- Class II
- Regulation Number
- 890.5650
- Review Panel
- PM
- Submission Type