ICE COMPRESSION FIRST, DUO, & MOOVE Systems
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by Mks Paris
Identifiers
- 510(k) Number
- K193079 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 ICE Compression First, Duo, and Moove Systems are powered inflatable tube massagers designed for cold and compression therapy. These devices deliver targeted cold and compression to reduce edema, swelling, and pain in post-surgical and acute injury settings, utilising anatomical splints for specific body regions such as the shoulder, wrist, knee, leg, hip, and back.
The system comprises a DC-powered control unit, an AC adapter, tubing, and anatomical splints. It operates as a reusable device with FDA 510(k) and MDD authorisations, classified under product code IRP as a Class II device. The systems are intended for use in clinical environments and are not MRI-safe. Each model is supplied with specific anatomical splints and requires proper storage to maintain functionality.
Frequently asked questions
What specific body regions can the ICE Compression systems target for therapy, and how are these regions accommodated in the design?
The ICE Compression First, Duo, and Moove Systems are designed to target anatomical regions such as the shoulder, wrist, knee, leg, hip, and back. Each model includes specialized anatomical splints tailored to these areas, ensuring precise application of cold and compression therapy to reduce edema, swelling, and pain in post-surgical or acute injury scenarios.
Are the ICE Compression systems reusable, and if so, what maintenance or care is required to ensure their functionality?
Yes, the ICE Compression systems are reusable devices. While the data does not specify maintenance details, proper storage is emphasized to maintain functionality. Users should follow manufacturer guidelines for cleaning, inspection, and storage to ensure the control unit, tubing, and anatomical splints remain effective and safe for repeated use.
How are the ICE Compression systems powered, and what accessories are included in the supply?
The systems are powered by a DC-powered control unit, which is paired with an AC adapter for operation. Each system includes tubing and anatomical splints designed for specific body regions, ensuring compatibility with the intended therapy areas. The supply does not include disposable components, as the device itself is reusable.
Are the ICE Compression systems safe for use in all clinical environments, and what limitations should clinicians be aware of?
The systems are intended for clinical use but are explicitly not MRI-safe, meaning they should not be used in or near MRI equipment. Clinicians should also ensure proper storage and handling to preserve functionality, as the device is reusable and designed for repeated use in post-surgical or acute injury settings.
What regulatory pathway was followed for the ICE Compression systems, and which advisory committee was involved?
The ICE Compression systems underwent a Traditional 510(k) review process in the U.S. and were classified under product code IRP as a Class II device. The review was conducted by the Physical Medicine (PM) Advisory Committee, and the decision was based on substantial equivalence to existing devices in this category.
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: ICE COMPRESSION FIRST, DUO, & MOOVE Systems, ICE COMPRESSION FIRST, DUO, & MOOVE Systems (K193079) - FDA 510 (k ..., ICE COMPRESSION FIRST, DUO, & MOOVE Systems — FDA K193079, ICE COMPRESSION FIRST, DUO, & MOOVE Systems
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K193079 | Class II | Active |
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Manufacturer
- Manufacturer
- Mks Paris
Sources (2)
- FDA 510(k) K193079 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 18, 2026