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510(k) Data Aggregation
K Number
K160431Device Name
ActiveCare Home
Manufacturer
MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
Date Cleared
2016-07-13
(148 days)
Product Code
JOW, REG
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ActiveCare+SFT®and ActiveCare+DTx® Systems are portable, ambulatory, sequential, intermittent pneumatic compression devices (IPCDs) prescribed by health care professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised, such as during and after major orthopaedic surgery procedures e.g. total joint (hip and knee) arthroplasty. They are in the clinical setting or home environment and can be provided directly to the patient for home use.
These devices are indicated for use in:
- · Preventing Deep Vein Thrombosis (DVT)
- · Diminishing post-operative pain and swelling
- Reducing wound healing time
· Patients at risk for Deep Vein Thrombosis (DVT) and related Pulmonary Embolism (PE) (Venous Thromboembolism (VTE))
- · Treatment of venous stasis
- · Treatment and assistance in healing: Stasis dermatitis, venous stasis ulcers, arterial and diabetic leg ulcers
- · Enhancing blood circulation
- · Treatment of chronic venous insufficiency
- · Reducing edema
The ActiveCare+SFT® and ActiveCare+DTx® Systems are intended to provide external compression in synchrony with the specific patient's natural venous blood flow return profile in order to achieve a high pulsatile venous blood flow. In addition, the ActiveCare+DTx® System can detect hemodynamic changes in venous blood flow.
Device Description
The ActiveCare Systems are portable, ambulatory, sequential, intermittent pneumatic compression devices (IPCDs) prescribed by healthcare professionals. The systems include a rechargeable battery powered option allowing patient mobility and ease of use. These devices simulate muscle contractions in order to treat or enhance blood flow velocity in individuals experiencing venous impairment or reduced pulsatility (dysfunction of the muscle pump) when blood flow may become challenged or compromised such as during and after major orthopedic surgery procedures e.g. total joint(hip and knee) arthroplasty. They are intended for use in the clinical setting or home environment, and can be provided directly to the patient for home use.
The modified ActiveCare@Home is different from the cleared device in the following:
- 1. The modified ActiveCare@Home was equipped with hardware Bluetooth Module.
- 2. Two new Software Blocks were added to its original Software, which were designed to:
- · Establish a communication between the ActiveCare main processor and the Bluetooth module (Bluetooth Communication)
- · Collect and reprocess data already being measured by the device in order to detect the number of the patient's steps generated during the treatment period (hereinafter referred to in this document as "Patient's Activity Index").
- 3. Three minor modifications were added to the ActiveCare@Home device GUI:
- · Reduction of the battery icon size in order to generate space for displaying the Activity Index graph mentioned above.
- · Displaying under the battery icon an estimation of the remained battery life time (appears only when the ActiveCare@Home device is powered by the internal battery).
- · Adding a 2D barcode icon to the Archives screen, this will include digital information, in addition to the same data which is displayed on the LCD screen verbally - for logistic.
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K Number
K140755Device Name
ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS
Manufacturer
MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
Date Cleared
2014-05-08
(43 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ActiveCare DVT, ActiveCare+SFT and ActiveCare+DTx Systems are prescriptive devices that induce Continuous Enhanced Circulation Therapy of the lower limbs. The Systems are intended for use in: Preventing Deep Vein Thrombosis (DVT). Enhancing blood circulation. Diminishing post-operative pain and swelling. Reducing wound-healing time. Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers. Treatment of chronic venous insufficiency. Reducing edema.
Device Description
The ActiveCare+DTx, ActiveCare+SFT and ActiveCare DVT Systems are prescriptive, pneumatic compression Systems designed to apply sequential compression to the lower limb. The control units of the Systems provide the user with several treatment options: compression of the foot - single or double, compression of the calf - single or double, compression of the thigh - single or double, and combined compression of any combination of two sleeves. The foot compression program is an intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent application of a pressure to a three-celled cuff sleeve.
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K Number
K110159Device Name
ACTIVECARE SFT
Manufacturer
MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
Date Cleared
2011-05-12
(113 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ActiveCare+SFT® System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs.
The ActiveCare+SFT® System is intended for use in:
- Preventing Deep Vein Thrombosis (DVT).
- Enhancing blood circulation.
- Diminishing post-operative pain and swelling.
- Reducing wound-healing time.
- Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers.
- Treatment of chronic venous insufficiency.
- Reducing edema.
Device Description
The ActiveCare+SFT® is a prescriptive, pneumatic compression system designed to apply sequential compression to the lower limb. The control unit of the ActiveCare+SFT® is light and compact, thus making it a portable ambulant system. The ActiveCare+SFT® provide the user with an option of battery operation in addition to the operation from the mains option. The ActiveCare+SFT® is easy to use and provides the user with several treatment options: compression of the foot - single or double, compression of the calf - single or double, compression of the Thigh - single or double, and combined compression of any combination of two sleeves.
The foot compression program is intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent application of a pressure to a three-celled cuff sleeve.
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K Number
K060146Device Name
ACTIVECARE ++ SYSTEM
Manufacturer
MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
Date Cleared
2006-03-08
(48 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ActiveCare®++ System is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs. The ActiveCare®++ System is intended for use in:
- Preventing Deep Vein Thrombosis (DVT). .
- Enhancing blood circulation. .
- Diminishing post-operative pain and swelling. .
- Reducing wound-healing time. .
- Treatment and assistance in healing: stasis dermatitis; . venous stasis ulcers; arterial and diabetic leg ulcers.
- Treatment of chronic venous insufficiency. .
- Reducing edema. .
Device Description
The ActiveCare®++ is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The control unit of the ActiveCare®++ is light and compact, thus making it a portable ambulant system. The ActiveCare®++ provides the user with an option of battery operation in addition to the operation from the mains option. The ActiveCare®++ is easy to use and provides the user with several treatment options: compression of the foot - single or double (either regular foot or foot booster), compression of the calf - single or double, compression of the Thigh - single or double, and combined compression of any combination of two sleeves.
The foot compression program is sequential intermittent pressure pulse application to a single celled foot sleeve. The calf and thigh compression program is a sequential intermittent gradient application of a pressure (s) a three-celled calf sleeve.
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K Number
K012994Device Name
WIZAIR DVT
Manufacturer
MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
Date Cleared
2002-03-27
(202 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
MEDICAL COMPRESSION SYSTEMS (DBN) LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The WizAir DVT™ is a prescriptive device that induces Continuous Enhanced Circulation Therapy of the lower limbs. The WizAir DVT™ is intended for use in: Preventing Deep Vein Thrombosis (DVT). Enhancing blood circulation. Diminishing post-operative pain and swelling. Reducing wound-healing time. Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers. Treatment of chronic venous insufficiency. Reducing edema.
Device Description
The WizAir DVT™ is a prescriptive, pneumatic compression device designed to apply sequential compression to the lower limb. The control unit of the WizAir DVT™ is light and compact, thus making it a portable ambulant system. The WizAir DVTTM provides the user with an option of battery operation in addition to the operation from the mains option. The WizAir DVT™ is easy to use and provides the user with several treatment options: compression of the foot - single or double, compression of the calf - single or double, compression of the Thigh - single or double, and combined compression of any combination of two cuffs. The foot compression program is sequential intermittent pressure pulse application to a single celled foot cuff. The calf and thigh compression program is a a sequential intermittent gradient application of a pressure to a three-celled calf cuff.
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