Identity
- Trade Name
- MOVES SLC FDA UDI
- Generic Name
- Portable electric ventilator FDA UDI
- Device Name
- Assy, MOVES SLC, Accessory Case FDA UDI
- Model / Reference
- 124847 FDA UDI
- Description
- Assy, MOVES SLC, Accessory Case FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10807141000121 FDA UDI
- 510(k) Number
- FDA Product Code
- BTL FDA 510(k)FDA UDICAW FDA UDIMWI FDA UDIBTA FDA UDI
- GMDN Term
- Portable electric ventilator FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 868.5925 FDA 510(k)
- Regulation Number
- 868.5925 FDA 510(k)FDA UDI868.5440 FDA UDI870.2300 FDA UDI878.4780 FDA UDI
- Advisory Committee
- Anesthesiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
No
The MOVES SLC is a powered emergency ventilator designed for resuscitation and mechanical ventilation. Classified as a Class II medical device, it integrates respiratory support with oxygen delivery, suction, and vital signs monitoring to sustain patient care in critical scenarios.
Supplied as a reusable device, the MOVES SLC is intended for use in emergency and austere environments, including military and humanitarian settings. Authorized under FDA 510K and MDD compliance, it is engineered for portability and ruggedness, ensuring reliable operation in field conditions. No specific sterility or MRI safety information is provided in the data.
Frequently asked questions
Is the MOVES SLC designed for single-use or can it be reused after cleaning and maintenance?
The MOVES SLC is explicitly described as a reusable device, meaning it is intended to be cleaned, maintained, and reused in multiple clinical or field settings. This design aligns with its purpose for emergency and austere environments, where portability and durability are prioritized over single-use convenience. No specific cleaning or reprocessing instructions are provided in the data, but the manufacturer’s intended use implies it must be properly serviced to ensure reliable operation.
What types of environments is the MOVES SLC intended for, and how does its design support those settings?
The MOVES SLC is engineered for emergency and austere environments, including military and humanitarian deployments. Its portability and ruggedness are key features, ensuring it can function reliably in challenging conditions where traditional hospital-grade equipment may not be feasible. The device integrates multiple functions—ventilation, oxygen delivery, suction, and vital signs monitoring—into a single unit, making it ideal for scenarios where space, power, or infrastructure are limited.
Does the MOVES SLC include any monitoring capabilities, and if so, what vital signs are tracked?
Yes, the MOVES SLC is designed to provide vital signs monitoring as part of its respiratory support functionality. While the exact parameters aren’t detailed in the data, the inclusion of monitoring aligns with its role in sustaining patient care during resuscitation or mechanical ventilation in critical scenarios. This feature helps clinicians assess patient stability in environments where continuous observation may be difficult.
How is the MOVES SLC regulated, and what does its classification as a Class II device imply for users?
The MOVES SLC is classified as a Class II medical device and has received FDA 510K clearance as well as compliance under the MDD (Medical Device Directive). This classification implies that while it poses moderate risk, it undergoes rigorous review to ensure safety and performance. For users, this means the device has undergone validation for its intended purposes—emergency ventilation, oxygen delivery, and suction—while still requiring adherence to manufacturer guidelines for proper operation, maintenance, and training.
Are there any specific storage requirements mentioned for the MOVES SLC, particularly regarding environmental conditions?
The provided data does not explicitly detail storage requirements such as temperature ranges, humidity levels, or protection from physical damage. However, given its portability and rugged design for field use, it is reasonable to infer that the device should be stored in a way that prevents exposure to extreme conditions (e.g., excessive heat, cold, or moisture) and potential impacts or contamination. Always follow the manufacturer’s instructions or maintenance protocols for optimal longevity and performance.
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, Military - Thornhill Medical, Home - Thornhill Medical, Portable Life-Support Device Provides Critical Care in Conflict ..., THORNHILL MEDICAL MOVES SLC OPERATOR'S MANUAL Pdf Download
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 | K161420 | Class II | Active |
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Manufacturer
- Manufacturer
- Thornhill Research Inc
- FDA Applicant
- Thornhill Research, Inc.
Sources (3)
- FDA 510(k) K161420 24 fields · synced Sep 18, 2026
- FDA UDI cfc02e28-500f-4612-b14d-5ecce4a24daf 35 fields · synced May 26, 2026
- EUDAMED 1 fields · synced May 28, 2026