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510(k) Data Aggregation
K Number
K241465Device Name
Midas Flowmeter; eAVS
Manufacturer
Parker Hannifin Corporation
Date Cleared
2024-09-19
(119 days)
Product Code
BZR, CBN
Regulation Number
868.5330Why did this record match?
Applicant Name (Manufacturer) :
Parker Hannifin Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Midas Flowmeter is intended for use as a continuous flow conscious sedation system to deliver a mixture of nitrous oxide and oxygen gases to a patient. When used with the electronic automatic vacuum switch (eAVS), the Midas Flowmeter is used to control the scavenging of waste analgesic gas.
Device Description
The Midas Flowmeter is used within a healthcare environment during a nitrous oxide (N20)/oxygen (O2) conscious sedation system. The device is a digitally controlled, software driven, continuous flow device that precisely meters nitrous oxide and oxygen medical gases and delivers gas mixtures to a conscious, spontaneously breathing patient. The Midas Flowmeter uses electronic mechanisms to control the flowrate and mixture percentage of gases delivered to a patient. The optional eAVS is an accessory to the Midas Flowmeter. It is used within the nitrous oxide/oxygen conscious sedation system to allow removal of waste analgesic gases through a connected vacuum source. The eAVS connects the exhalation line of the patient's breathing circuit to vacuum tubing from the vacuum source and controls the vacuum flowrate (i.e., scavenging flowrate). The eAVS is specifically designed to work with the Midas Flowmeter and all functionality control of the eAVS has been integrated into the user interface of the Midas Flowmeter.
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K Number
K223452Device Name
Nitronox Scavenger Plus
Manufacturer
Parker Hannifin Corporation
Date Cleared
2023-03-05
(110 days)
Product Code
CBN
Regulation Number
868.5430Why did this record match?
Applicant Name (Manufacturer) :
Parker Hannifin Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nitronox® Scavenger Plus is intended to control the vacuum flowrate for scavenging of waste analgesic gas.
Device Description
The Nitronox® Scavenger Plus (Scavenger Plus) is used within a nitrous oxide/oxygen conscious sedation system to allow removal of waste analgesic gases through a connected vacuum source. The device is used during a dental or medical procedure in a healthcare facility environment. The device is not intended to be used for general anesthesia. The Scavenger Plus is operated by a licensed healthcare professional during conscious sedation of a patient.
The Scavenger Plus connects the exhalation line of the patient's breathing circuit to vacuum tubing from the vacuum source and controls the vacuum flowrate (i.e., scavenging flowrate). The rate at which the gas is removed (i.e., scavenged) is specified by the Scavenger Plus, which uses a control knob and reservoir bag to limit the amount of vacuum applied to the exhalation line of the breathing circuit.
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K Number
K171334Device Name
Indego
Manufacturer
Parker Hannifin Corporation
Date Cleared
2017-09-08
(123 days)
Product Code
PHL
Regulation Number
890.3480Why did this record match?
Applicant Name (Manufacturer) :
Parker Hannifin Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Indego® orthotically fits to the lower limbs and the trunk; the device is intended to enable individuals with spinal cord injury at levels T3 to L5 to perform ambulatory functions with supervision of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels C7 to L5 to perform ambulatory functions in rehabilitations in accordance with the user assessment and training certification program. The Indego is not intended for sports or stair climbing.
Device Description
Parker Hannifin's Indego® device is a wearable powered exoskeleton that actively assists individuals to stand and walk; these are patients with walking impairments resulting from lower extremity weakness or paralysis. The Indego consists of snap-together components weighing 26 pounds total. The hip component houses a rechargeable battery pack, central processor, and Bluetooth radio, while each upper leg component houses two motors as well as embedded sensors and controllers. On-board microprocessors receive signals from integrated sensors which provide information on the user's posture and tilt. This allows the device to function in a manner similar to the Segway personal mobility device, which is controlled by the user's tilt. A user similarly controls of the Indego by means of postural changes (e.g., to walk forward, the user just leans forward). The technology of the design links the low weight and low profile to advanced battery technology (smaller size), motors (smaller and more powerful), and micro controllers (state-of-the art). Visual cues from the LED lights on the hip and vibratory feedback inform both the patient and therapist or trained support person of the status and mode of operation. The Indego controls are self-contained, with forearm crutches or a walker used solely for stability. Users can perform sit-to-stand and stand-to-sit transitions and walk along even or uneven terrain up to about five degree (5°) grades. Taller torso "wings" are provided to support users who may need additional trunk support while walking. A physical therapist can configure, operate, and monitor the device during therapy and training to make adjustments as needed. This is achieved through the support of a wireless application that will run on mobile/wifi connected smart devices such as an iPod or iPhone. The patient and physical therapist will be able to work in concert to achieve the actions of transitioning from sitting to standing, standing to walking, stop walking, and return from standing to sitting. The untethered, free roaming design of the device will allow it to be utilized in multiple indoor and outdoor locations in either a rehabilitation setting with a certified Indego Specialist or a personal setting with a trained support person.
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K Number
K152416Device Name
Indego
Manufacturer
PARKER HANNIFIN CORPORATION
Date Cleared
2016-02-26
(184 days)
Product Code
PHL
Regulation Number
890.3480Why did this record match?
Applicant Name (Manufacturer) :
PARKER HANNIFIN CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Indego® orthotically fits to the lower limbs and the trunk; the device is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory functions with supervision of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels T4 to T6 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. The Indego is not intended for sports or stair climbing.
Device Description
Parker Hannifin's Indego® device is a wearable powered exoskeleton that actively assists individuals to stand and walk. Unique in design, the Indego consists of five (5) snap-together components (the lumbar/hip section, right and left upper leg sections, and right and left lower leg sections) weighing 26 pounds total. The hip component houses a rechargeable battery pack, central processor, and Bluetooth module, while each upper leg component houses two motors as well as embedded sensors and controllers.
On-board microprocessors receive signals from integrated sensors which provide information on the user's posture and tilt. This allows the device to function in a manner similar to the Segway personal mobility device, which is controlled by the user's tilt. A user similarly controls the Indego by means of postural changes (e.g., to walk forward, the user just leans forward). The technology of the design links the low weight and low profile to battery technology (smaller size), motors (smaller and more powerful), and micro controllers. Visual cues from LED lights on the hip unit and vibratory feedback inform both the therapist and patient of the status and mode of operation.
The Indego controls are self-contained, with crutches or a walker used solely for stability. Users can perform sit-to-stand and stand-to-sit transitions and walk along even or uneven terrain up to about five degree (5°) grades. Taller torso "wings" are provided to support users who may need additional trunk support while walking. A physical therapist can configure, operate, and monitor the device during therapy and training to make adjustments as needed. This is achieved through the support of a wireless application that will run on mobile/wifi connected smart devices such as an iPod or iPhone. Through the use of a Bluetooth connection, the Indego device's mode of operational parameters such as gait speed and step length/height, will be able to be changed or modified in real time. The device can be utilized in multiple indoor and outdoor locations within a rehabilitation setting or personal setting.
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