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Moves

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K093261

by Thornhill Research Inc

Identifiers

510(k) Number
K093261 FDA 510(k)
FDA Product Code
BTL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.5925 FDA 510(k)
Regulation Number
868.5925 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The MOVES SLC is a portable, powered emergency ventilator designed for use in critical care scenarios, including austere, combat, or humanitarian environments. As classified under FDA’s device type for powered emergency ventilators (resuscitators), it provides mechanical ventilation to support respiratory function in patients requiring immediate life support.

This device is supplied as a micro-integrated system combining an oxygen concentrator, a ventilator with oxygen-conserving capabilities, suction, and vital signs monitoring. It is intended for single-use or reusable applications in emergency settings, with regulatory authorizations including FDA 510(k) clearance and compliance with the Medical Device Directive (MDD). The MOVES SLC operates in environments where traditional medical infrastructure may be unavailable, adhering to standards for portable life support systems.

Frequently asked questions

Is the MOVES SLC designed for use in environments where traditional medical infrastructure is unavailable, and if so, what types of scenarios does it support?

Yes, the MOVES SLC is specifically designed for critical care scenarios where traditional medical infrastructure is unavailable, such as austere, combat, or humanitarian environments. It provides mechanical ventilation to support respiratory function in patients requiring immediate life support, making it ideal for settings where portable and self-contained life support is essential.

How is the MOVES SLC supplied, and can it be reused or is it intended for single-use?

The MOVES SLC is supplied as a micro-integrated system combining an oxygen concentrator, a ventilator with oxygen-conserving capabilities, suction, and vital signs monitoring. It is intended for both single-use and reusable applications in emergency settings, depending on operational needs and protocols.

What regulatory pathways has the MOVES SLC followed, and which governing bodies have authorized its use?

The MOVES SLC has received FDA 510(k) clearance and complies with the Medical Device Directive (MDD). These authorizations confirm its substantial equivalence to a predicate device under FDA regulations and adherence to European medical device standards, ensuring its suitability for emergency ventilator applications.

Does the MOVES SLC include additional features beyond basic ventilation, and if so, what are they?

Yes, the MOVES SLC is not just a ventilator—it integrates an oxygen concentrator, oxygen-conserving capabilities, suction functionality, and vital signs monitoring into a single portable unit. This comprehensive design allows it to provide respiratory support, manage airway clearance, and track patient vitals in emergency scenarios.

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: MOVES® SLC™ - Thornhill Medical, Home - Thornhill Medical, MOVES SLC by THORNHILL RESEARCH INC | FDA 510 (k) Summary, Thornhill Medical MOVES® SLC™ Standard System - Panakeia, LLC.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Thornhill Research Inc
FDA Applicant
Thornhill Research, Inc.

Sources (2)

  • FDA 510(k) K093261 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced Jun 1, 2026