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510(k) Data Aggregation
K Number
K240499Device Name
ARTAIRA Arterial Compression Device (AACD01)
Manufacturer
AIROS Medical, Inc.
Date Cleared
2024-10-11
(234 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
AIROS Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ARTAIRA Arterial Compression Device's is an intermittent pneumatic compression device intended for treatment of patients with the following conditions:
- · Intermittent claudication
- · Rest pain
- Diabetic Foot
- · Ischemic neuritis
- · Arterial ulcers
- · Gangrene
- Poor runoff.
Device Description
The AIROS ARTAIRA Arterial Compression Device is an intermittent pneumatic compression device intended to increase blood flow and increase circulation in the lower extremities by providing timed compression to the foot/ankle and calf. The device consists of a hard casing with an air pump, a set of air valves, an air reservoir controlled by the device software to deliver a rapid burst of pneumatic pressure to the treatment area. The device connects through air tubing to a pair of compression garments (left and right leg), each with two air chambers: one on the underfoot (Foot/Ankle chamber) and one on the calf area (Calf Chamber). The device can either be used with one garment or two garments. The system is intended to be used primarily at home settings according to a physician-prescribed therapy.
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K Number
K193068Device Name
AIROS 8 Sequential Compression Device
Manufacturer
AIROS Medical, Inc.
Date Cleared
2019-12-04
(30 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
AIROS Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AIROS 8 Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions:
- Lymphedema
- Venous stasis ulcers
- Venous insufficiency
- Peripheral edema
The device is safe for both home and hospital use.
Device Description
The AIROS 8 Sequential Compression Device is a gradient pneumatic compression device. The device is used for treatment and management of venous or lymphatic disorders. The application of gradient sequential compression increases blood flow and encourages extracellular fluid clearance.
The AIROS 8 system consists of the device and 8-chambered garments. The device provides cycles of compressed air and sequentially inflates the garments from distal to proximal.
The digitally-controlled device consists of an electrically generated source of compressed air, tubing to convey the pressurized air to the sleeve, and like the predicate, pressure is applied cyclically for a specified period of time, according to the physician's prescription.
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K Number
K193069Device Name
AIROS 6 Sequential Compression Device
Manufacturer
AIROS Medical, Inc.
Date Cleared
2019-12-04
(30 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
AIROS Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AIROS 6 Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions:
- Lymphedema
- Venous stasis ulcers
- Venous insufficiency
- Peripheral edema
The device is safe for both home and hospital use.
Device Description
The AIROS 6 Sequential Compression Device is a gradient pneumatic compression device. The device is used for treatment and management of venous or lymphatic disorders. The application of gradient sequential compression increases blood flow and encourages extracellular fluid clearance.
The AIROS 6 system consists of the device and 6-chambered garments. The device provides cycles of compressed air and sequentially inflates the garments from distal to proximal.
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K Number
K172770Device Name
AIROS 6 Sequential Compression Device
Manufacturer
AIROS Medical, Inc.
Date Cleared
2018-06-22
(281 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
AIROS Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AIROS 6 Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions:
- · Lymphedema
- Venous stasis ulcers
- · Venous insufficiency
- · Peripheral edema
The device is safe for both home and hospital use.
Device Description
The AIROS 6 Sequential Compression Device is a gradient pneumatic compression device. The device is used for treatment and management of venous or lymphatic disorders. The application of gradient sequential compression increases blood flow and encourages extracellular fluid clearance.
The AIROS 6 system consists of the device and 6-chambered garments. The device provides cycles of compressed air and sequentially inflates the garments from distal to proximal.
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K Number
K172779Device Name
AIROS 8 Sequential Compression Device
Manufacturer
AIROS Medical, Inc.
Date Cleared
2018-06-22
(281 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
AIROS Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AIROS 8 Sequential Compression Device utilizes gradient pneumatic compression, which is intended for treatment of patients with the following conditions:
- · Lymphedema
- Venous stasis ulcers
- · Venous insufficiency
- · Peripheral edema
The device is safe for both home and hospital use,
Device Description
The AIROS 8 Sequential Compression Device is a gradient pneumatic compression device. The device is used for treatment and management of venous or lymphatic disorders. The application of gradient sequential compression increases blood flow and encourages extracellular fluid clearance.
The AIROS 8 system consists of the device and 8-chambered garments. The device provides cycles of compressed air at certain adjustable pressures, and sequentially inflates the garments from distal to proximal. The pressure at each chamber can be individually adjusted to accommodate different therapy needs.
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