Identifiers
- 510(k) Number
- K253150 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 Cryon-X Cold Compression is a Powered Inflatable Tube Massager designed for physical medicine applications. It delivers targeted cold therapy combined with compression to reduce inflammation, alleviate pain, and promote tissue recovery. The device utilises inflatable technology to apply controlled pressure while maintaining a consistent cold temperature, aiding in post-injury or post-surgical rehabilitation.
This device is intended for single-use or reusable clinical settings, depending on the model variant, and is classified as a Class II medical device under FDA regulations. It is supplied sterile or non-sterile based on the specific model, with various sizes available to accommodate different anatomical regions. The Cryon-X Cold Compression has received FDA 510(k) clearance under the Special 510(k) Review Process and is regulated under 21 CFR 890.5650. Compliance with MRI safety standards is confirmed for non-ferromagnetic materials.
Frequently asked questions
What is the Cryon-X Cold Compression used for?
The Cryon-X Cold Compression is designed for physical medicine applications to reduce inflammation, alleviate pain, and promote tissue recovery. It delivers controlled cold therapy combined with compression, making it ideal for post-injury or post-surgical rehabilitation. The device’s inflatable technology ensures consistent pressure and temperature, aiding in effective recovery.
Is the Cryon-X Cold Compression single-use or reusable?
The Cryon-X Cold Compression is available in both single-use and reusable variants, depending on the specific model. This flexibility allows clinical settings to choose based on their operational needs, ensuring proper hygiene and compliance with medical protocols.
What sizes and sterility options are available for the Cryon-X Cold Compression?
The Cryon-X Cold Compression comes in multiple sizes to accommodate different anatomical regions. Sterility options vary by model—some are supplied sterile for clinical use, while others are non-sterile. Always refer to the product documentation or packaging to confirm the specific model’s sterility and size.
Can the Cryon-X Cold Compression be used in MRI environments?
Yes, the Cryon-X Cold Compression is designed with non-ferromagnetic materials, ensuring compliance with MRI safety standards. This allows for safe use in MRI environments without interference or risk to the patient.
What regulatory approvals does the Cryon-X Cold Compression hold?
The Cryon-X Cold Compression has received FDA 510(k) clearance under the Special 510(k) Review Process, confirming its substantial equivalence to a predicate device. It is classified as a Class II medical device under FDA regulations and is regulated under 21 CFR 890.5650.
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: PDF October 24, 2025 JKH Health Co., Ltd. - accessdata.fda.gov, Cryon-X Cold Compression (K253150) — FDA 510 (k) | Innolitics, Cryon-X Cold Compression (K253150) | Medical Device Navigator, Cryon-X Iceless Cold Therapy Devices with Compression, Cold Compression Therapy Unit | Cryon-X One
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K253150 | Class II | Active |
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Manufacturer
- Manufacturer
- JKH Health Co., Ltd.
Sources (1)
- FDA 510(k) K253150 24 fields · synced Oct 1, 2026