Cryopush Cold Compression Device (A02-P-001)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K253076 FDA 510(k)
- FDA Product Code
- IRP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5650 FDA 510(k)
- Regulation Number
- 890.5650 FDA 510(k)
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cryopush Cold Compression Device (A02-P-001) is a powered inflatable tube massager designed for cold therapy applications. It delivers intermittent pneumatic compression combined with cryotherapy to targeted body areas, aiding in pain relief, inflammation reduction, and tissue recovery.
This device is battery-powered, featuring a 2600mAh rechargeable lithium battery enabling up to eight hours of continuous use. Supplied as a single-use or reusable system (as per clinical setting requirements), it operates in non-MRI environments and includes multiple body-part-specific wraps. Authorised under FDA 510K and MDR, it adheres to Class II regulatory standards for physical medicine applications.
Frequently asked questions
What types of body areas can the Cryopush Cold Compression Device be used on, and how does it differ from standard cold therapy methods?
The Cryopush Cold Compression Device is designed for targeted body areas and combines intermittent pneumatic compression with cryotherapy to deliver both massage and cold therapy simultaneously. Unlike standard cold therapy (e.g., ice packs), it uses inflatable wraps tailored for specific body parts, providing dynamic compression while cooling the tissue. This dual-action approach aims to enhance pain relief, reduce inflammation, and improve tissue recovery more effectively than passive cold therapy alone.
Is the Cryopush Cold Compression Device reusable, and if so, what are the key considerations for maintenance and longevity?
The Cryopush Cold Compression Device can be supplied as either single-use or reusable, depending on clinical setting requirements. If reusable, proper cleaning and disinfection per manufacturer guidelines are essential to maintain sterility and functionality. The device’s battery-powered operation (2600mAh lithium-ion) and inflatable wraps should be inspected for wear, and the battery should be recharged regularly to ensure up to eight hours of continuous use per charge. Follow the manufacturer’s instructions to extend the device’s lifespan.
Can this device be used in environments where MRI scans are performed, and what safety precautions should be taken?
The Cryopush Cold Compression Device is not designed for MRI environments. It is explicitly labeled for use in non-MRI settings only, as its components (e.g., battery, electronics, and inflatable tubes) may interfere with MRI compatibility. If used near MRI areas, ensure it is powered off and removed to prevent potential hazards to patients or equipment.
How does the battery life of the Cryopush Cold Compression Device support clinical workflows, and what charging options are available?
The device features a 2600mAh rechargeable lithium battery, providing up to eight hours of continuous use on a single charge, which aligns well with typical clinical or post-procedure recovery sessions. It is designed for convenience, allowing for extended therapy sessions without frequent interruptions. Charging can be done via the included USB port, ensuring readiness for repeated use in clinical or home settings.
What regulatory pathways has the Cryopush Cold Compression Device followed, and what does this mean for healthcare providers?
The Cryopush Cold Compression Device has been authorized through FDA 510(k) clearance and MDR (Medical Device Regulation) compliance, adhering to Class II regulatory standards for physical medicine applications. This means it has undergone rigorous evaluation to ensure safety and performance, giving healthcare providers confidence in its clinical use for pain relief, inflammation reduction, and tissue recovery. The device’s classification under Physical Medicine reflects its intended use in therapeutic settings.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Cold Compression Device | Battery-Powered Portable Cryo ... - CryoPush, Cold Compression Device | Battery Powered Portable Iceless Cold Therapy ..., Cryopush Cold Compression Device (A02-P-001) (K253076 ... - fda ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K253076 | Class II | Active |
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Manufacturer
- Manufacturer
- Chengdu Cryo-push Medical Technology Co., Ltd.
- FDA Applicant
- Chengdu Cryo-Push Medical Technology Co.,Ltd
Sources (2)
- FDA 510(k) K253076 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 28, 2026