Hot and Cold Compression System (A02-C-032)— 510(k) K252386
Substantially EquivalentChengdu Cryo-Push Medical Technology Co.,Ltd
FDA 510(k) clearance K252386 for Hot and Cold Compression System (A02-C-032), Substantially Equivalent on 2026-04-03. Applicant: Chengdu Cryo-Push Medical Technology Co.,Ltd. Device class: 2.
Summary
Chengdu Cryo-Push Medical Technology's Hot and Cold Compression System (A02-C-032) is filed under product code IRP (Massager, Powered Inflatable Tube).
Class II, 21 CFR 890.5650. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Chengdu Cryo-Push Medical Technology filed from China, with the city field reading 611137. The decision came 246 calendar days after FDA received it (July 31, 2025 to April 3, 2026).
Clearance details
- Applicant
- Chengdu Cryo-Push Medical Technology Co.,Ltd
- Product code
- Product code IRP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5650
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- 611137, CN
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More clearances from Chengdu Cryo-Push Medical Technology Co.,Ltd
view allData sourced from openFDA. This site is unofficial and independent of the FDA.