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510(k) Data Aggregation
K Number
K161420Device Name
MOVES SLC
Manufacturer
THORNHILL RESEARCH INC.
Date Cleared
2017-06-06
(379 days)
Product Code
BTL, BTA, CAW, MWI
Regulation Number
868.5925Why did this record match?
Applicant Name (Manufacturer) :
THORNHILL RESEARCH INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MOVES® SLC™ is a portable computer controlled, electrically powered emergency ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
a. Suction
The MOVES® SLC™ suction pump is intended for aspiration and removal of fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system.
b. Supplementary Oxygen
The MOVES® SLC™ is intended to provide supplemental oxygen enriched air to patients that require supplemental oxygen.
c. Patient Monitoring
The MOVES® SLC™ is intended to monitor physiological parameters of patients and provide these parameters to a health care provider for interpretation in the form of physiological data and system alarms. Physiological data and system alarms will be available to the care provider from the monitor.
Device Description
The MOVES® SLC™ (SLC) is an upgraded version of the cleared MOVES® SLC™ device (K140049), a portable multifunction patient support and monitoring system with the following capabilities:
- Computer controlled, electrically powered circle ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
- Delivery of oxygen-enriched air that may be supplied from an external oxygen source or generated internal to the system with the on-board oxygen concentrator.
- Patient monitoring functions including the following patient parameters: Pulse Rate, Noninvasive BP (NIBP), Invasive BP (IBP), SPO2, Temperature, Respiration Rate, CO2, and O2.
- Suction/aspirator pump for medical suction procedures where secretions, blood and other body fluids must be removed through the application of continuous negative pressure.
The MOVES® SLCTM is capable of operating under battery power or external AC supply. It includes a handle and mounting equipment that allows it to attach to a stretcher.
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K Number
K140264Device Name
MADM
Manufacturer
THORNHILL RESEARCH INC.
Date Cleared
2015-01-05
(336 days)
Product Code
BSZ, CCK
Regulation Number
868.5160Why did this record match?
Applicant Name (Manufacturer) :
THORNHILL RESEARCH INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MADM™ is intended to deliver volatile anesthetic to a patient when placed in either circle or open anesthetic circuits. It vaporizes Isoflurane and Sevoflurane and delivers the vaporized anesthetic agent into the inspiratory limb of the breathing circuit.
MADM™ is also intended to monitor respiratory rate, CO2, and the anesthetic gases Isoflurane and Sevoflurane. It is intended to be connected to a patient breathing circuit for monitoring of patients to whom it is delivering volatile anesthetic gases.
Device Description
The MADM™ system is a portable vaporizer capable of delivering anesthetic to the inspiratory limb of a breathing circuit. Unlike other in-line vaporizers, MADMTM can be inserted into a circle system where some exhaled anesthetic is rebreathed. The MADM™ system measures the anesthetic concentration of incoming gas and reduces the anesthetic output to ensure the anesthetic concentration of gas delivered to the patient is as set on the dial.
MADM™ includes an internal battery backup capable of powering the device for 20 minutes, and an optional external battery base with hot swappable batteries capable of powering the system for over two hours. Anesthetic is stored in custom single agent anesthetic canisters.
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K Number
K140049Device Name
MOVES SLC
Manufacturer
THORNHILL RESEARCH INC
Date Cleared
2014-05-29
(140 days)
Product Code
BTL, BTA, CAW, MWI
Regulation Number
868.5925Why did this record match?
Applicant Name (Manufacturer) :
THORNHILL RESEARCH INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MOVES® SLC™ is a portable computer controlled electrically powered emergency transport ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require mechanical ventilation.
MOVES® SLC™ is intended to deliver high inspired oxygen concentrations to spontaneously breathing patients who require elevated inspired oxygen.
MOVES® SLC™ is intended to be used in a transport or emergency setting on adult patients who weigh between 40kg and 120kg.
MOVES® SLC™ provides the following supplemental functions for patients that it is ventilating or supplying with supplemental oxygen:
- Suction a.
The MOVES® SLC™ suction pump is intended for aspiration and removal of fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system.
- Supplementary Oxygen b.
The MOVES® SLCTM is intended to provide supplemental oxygen enriched air to patients that require supplemental oxygen.
- c. Patient Monitoring
The MOVES® SLC™ is intended to monitor physiological parameters of patients and provide these parameters to a health care provider for interpretation in the form of physiological data and system alarms. Physiological data and system alarms will be available to the care provider from the monitor.
Device Description
The MOVES® SLC™ (SLC) is an upgraded version of the cleared MOVES® device (K093261), a portable multifunction patient support and monitoring system with the following capabilities:
- . Computer controlled, electrically powered circle ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
- Delivery of oxygen-enriched air that may be supplied from an external oxygen . source or generated internal to the system with the on-board oxygen concentrator.
- Patient monitoring functions including the following patient parameters: Pulse . Rate, Noninvasive BP (NIBP), Invasive BP (IBP), SPO2, Temperature, Respiration Rate, CO2, and O2.
- Suction/aspirator pump for medical suction procedures where secretions, blood . and other body fluids must be removed through the application of continuous negative pressure.
The MOVES® SLCTM is capable of operating under battery power or external AC supply. It includes a handle and mounting equipment that allows it to attach to a stretcher.
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K Number
K093261Device Name
MOVES
Manufacturer
THORNHILL RESEARCH INC
Date Cleared
2010-03-26
(158 days)
Product Code
BTL
Regulation Number
868.5925Why did this record match?
Applicant Name (Manufacturer) :
THORNHILL RESEARCH INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MOVES™ is a portable computer controlled electrically powered emergency transport ventilator intended to provide continuous or intermittent ventilatory support for the care of adults who require mechanical ventilation.
The MOVES™ is intended to deliver high inspired oxygen concentrations via the MOVES™ O2 mask to spontaneously breathing patients who require elevated inspired oxygen.
MOVESTM is intended to be used in a transport or emergency setting on adult patients who weigh between 40 and 120kg.
MOVES™ provides the following supplemental functions for patients that it is ventilating or to whom it is delivering elevated inspired oxygen:
a. Suction
The MOVES™ suction pump is intended for aspiration and removal of fluids, tissue (including bone), gases, bodily fluids or infectious materials from wounds or from a patient's airway or respiratory support system.
b. Supplementary Oxygen
The MOVESTM is intended to provide supplemental oxygen enriched air to patients that require supplemental oxygen.
C. Patient Monitoring
The MOVESTM is intended to monitor physiological parameters of patients and provide these parameters to a health care provider for interpretation in the form of physiological data and system alarms. Physiological data and system alams will be available to the care provider from the monitor.
Device Description
The MOVES™ is a portable multifunction patient support and monitoring system with the following capabilities:
- Computer controlled, electrically powered circle ventilator intended to provide . continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.
- . Delivery oxygen-enriched air that may be supplied from an external oxygen source or generated internal to the system with the on-board oxygen concentrator.
- Patient monitoring functions including the following patient parameters: Pulse . Rate, Noninvasive BP (NIBP), Invasive BP (IBP), SPO2, Temperature, Respiration Rate, CO2, and O2.
- Suction/aspirator pump for medical suction procedures where secretions, blood . and other body fluids must be removed through the application of continuous negative pressure.
The moves is capable of operating under battery power or external AC supply. It includes a handle and mounting equipment that allows it to attach to a stretcher.
Ask a Question
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