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510(k) Data Aggregation
K Number
K230028Device Name
Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly
Manufacturer
Cardinal Health200, LLC
Date Cleared
2023-04-03
(89 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Cardinal Health200, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended Use
The Kendall SCD SmartFlow Compression system (hereby referenced as "Kendall SCD SmartFlow") is designed to apply Intermittent Pneumatic Compression (IPC) to increase venous blood flow in atrisk patients in order to help vein thrombosis and pulmonary embolism. The system, additionally, will enhance circulation and treats venous stasis, addressing associated symptoms such as pain and swelling. The system consists of the tubing assemblies (provided with the controller) and single-patient use garments (purchased separately from this controller).
The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression cycle, the controller measures the time it takes for the limbs to refill with blood and adjusts the compression frequency to maximize flow rate.
The system may be used for all ages of adults and children when indicated to apply intermittent pneumatic compression. System is also designed to increase venous blood flow in at-risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism. The system is intended for use in a clinical setting by health care professionals.
Indications
Leg Compression
The use of the Kendall SCD SmartFlow Compression System with Sequential, Gradient, Circumferential (SGC) compression is indicated for:
- · Deep Vein Thrombosis and Pulmonary Embolism Prophylaxis.
- · Treatment of pain and swelling related to venous stasis
- · Circulation enhancement
The use of the Kendall SCD SmartFlow Compression System with uniform, posterior compression is indicated for:
· Deep Vein Thrombosis Prophylaxis.
Foot Compression
The use of the Kendall SCD SmartFlow Compression System with foot compression is indicated for:
- · Circulation Enhancement
- · Deep Vein Thrombosis Prophylaxis
- · Edema Acute
- · Edema Chronic
- · Extremity Pain Incident to Trauma or Surgery
- · Leg Ulcers
- · Venous Stasis
Device Description
The Kendall SCD SmartFlow Compression system (hereby referenced as "Kendall SCD SmartFlow") is designed to apply Intermittent Pneumatic Compression (IPC) to increase venous blood flow in atrisk patients in order to help vein thrombosis and pulmonary embolism. The system, additionally, will enhance circulation and treats venous stasis, addressing associated symptoms such as pain and swelling. The system consists of the tubing assemblies (provided with the controller) and single-patient use garments (purchased separately from this controller).
The garments, both leg sleeves and foot cuffs, compress the limbs to enhance venous blood movement. After the compression cycle, the controller measures the time it takes for the limbs to refill with blood and adjusts the compression frequency to maximize flow rate.
The system may be used for all ages of adults and children when indicated to apply intermittent pneumatic compression. System is also designed to increase venous blood flow in at-risk patients, including bariatric and morbidly obese patients, in order to help prevent deep vein thrombosis and pulmonary embolism. The system is intended for use in a clinical setting by health care professionals.
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