Cold Compression Wrap Pro
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- Cold Compression Wrap EUDAMED
- Model / Reference
- KRP/QN-(A1,B1,C1,D1,E1,F1,G1,H1,K1,N1); A02-C-(020,021,022,025)-M; A02-C-023-(M,L) EUDAMEDKRP/QN-A1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973641881014 EUDAMED
- Basic UDI-DI
- 697364188QN1UV EUDAMED
- 510(k) Number
- K230524 FDA 510(k)
- FDA Product Code
- IRP FDA 510(k)
- EMDN Code
- M9001 CRYOTHERAPY AND THERMOTHERAPY DEVICES EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 890.5650 FDA 510(k)
- Regulation Number
- 890.5650 FDA 510(k)
- Market of Registration
- France EUDAMED
- Advisory Committee
- Physical Medicine FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Cold Compression Wrap Pro is a Powered Inflatable Tube designed for cold compression therapy. It delivers controlled cold therapy to reduce swelling, inflammation, and pain by combining cryotherapy with compression, typically used in physical medicine settings for musculoskeletal injuries or postoperative recovery.
This device is supplied as a single-use or reusable system, depending on model specifications, and is intended for use in clinical or home settings. It operates under FDA 510K clearance and MDR authorization, with multiple registration numbers listed for compliance. The device is non-MRI safe and available in various sizes as indicated by the registration numbers. Storage and usage instructions are provided by the manufacturer to ensure proper application and maintenance.
Frequently asked questions
What clinical settings or conditions is the Cold Compression Wrap Pro primarily used for?
The Cold Compression Wrap Pro is designed for cold compression therapy to reduce swelling, inflammation, and pain, commonly applied in physical medicine settings. It is particularly suited for musculoskeletal injuries or postoperative recovery, where controlled cold therapy combined with compression can aid in healing and patient comfort.
Is the Cold Compression Wrap Pro safe to use in an MRI environment?
No, the Cold Compression Wrap Pro is explicitly labeled as non-MRI safe, meaning it should not be used in or near an MRI scanner. Always verify compatibility with your facility’s MRI protocols before use.
How do I determine the correct size for a patient when selecting a Cold Compression Wrap Pro?
The device is available in multiple sizes, as indicated by the registration numbers (e.g., 3012184077, 3027321925, etc.). The manufacturer provides sizing guidelines in the included instructions to ensure proper fit for the targeted anatomical area (e.g., ankle, knee, shoulder). Always follow these instructions to avoid improper compression or therapy delivery.
Can the Cold Compression Wrap Pro be reused, or is it intended for single-use only?
The Cold Compression Wrap Pro is supplied as either single-use or reusable, depending on the specific model. The manufacturer’s instructions clarify usage limitations for each variant. Reusable models require proper cleaning and maintenance per the provided guidelines to ensure hygiene and functionality.
What regulatory pathways does the Cold Compression Wrap Pro follow, and how does this affect its use?
The device is cleared via FDA 510(k) (K230524) under the Traditional clearance type and authorized under the EU MDR. This means it meets U.S. and EU regulatory standards for safety and effectiveness in its intended use. Always verify compliance with local regulations before purchasing or deploying, as registration numbers (e.g., 3012184077) may vary by region.
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 Therapy Machine ODM/OEM Manufacturer, Chengdu Cryo-Push Medical Technology Co., Ltd., Chengdu Cryo-Push Medical Technology Co., Ltd. - Cold Compression ..., Cold Compression Wrap Manufacturer | Keruipu
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 | K230524 | 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) K230524 24 fields · synced Sep 20, 2026
- EUDAMED 0a5bfafe-f0bf-44e6-bd17-58bdca21cdc7 61 fields · synced Jul 25, 2026