Cryopush Cold Compression Device (A02-P-001)— 510(k) K253076
Substantially EquivalentChengdu Cryo-Push Medical Technology Co.,Ltd
FDA 510(k) clearance K253076 for Cryopush Cold Compression Device (A02-P-001), Substantially Equivalent on 2026-04-02. Applicant: Chengdu Cryo-Push Medical Technology Co.,Ltd. Device class: 2.
Summary
Chengdu Cryo-Push Medical Technology's Cryopush Cold Compression Device (A02-P-001) 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. It came in as a Traditional 510(k).
Chengdu Cryo-Push Medical Technology filed from Chengdu, China. The record shows 191 calendar days from receipt to decision (September 23, 2025 to April 2, 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
- Chengdu, CN
Recent devices under product code IRP
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- K262812 — Air compression massager (ACM-C1, ACM-C2, ACM-C3, ACM-C4, ACM-C5, ACM-C6, ACM-C7, ACM-C8, ACM-C9, ACM-5C1, ACM-5C2, ACM-5C3, ACM-5C4, ACM-5C5, ACM-5C6, ACM-5C7, ACM-5C8, ACM-5C9)
- K260944 — ManaCold Compression System
- K260529 — Air Compression Massager (HY-1165)
- K260948 — Air Compression Massager (EP30B001 I)
More clearances from Chengdu Cryo-Push Medical Technology Co.,Ltd
view allData sourced from openFDA. This site is unofficial and independent of the FDA.