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Found 17 results
510(k) Data Aggregation
K Number
K214053Device Name
Amputee Garment for use with Lympha Press Optimal Plus
Manufacturer
Mego Afek AC Ltd.
Date Cleared
2022-04-14
(108 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Mego Afek AC Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Amputee Garment for use with Lympha Press Optimal Plus is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as: · Primary Ivmphedema · Secondary Ivmphedema - - · Venous insufficiency - Venous stasis ulcers - · Dysfunction of the muscle pump - · Post mastectomy edema - · Edema following trauma and sports issues - · Post immobilization edema - · Reduction of wound healing time - · Reduction of pain and swelling after injury and surgery - · The device may also be beneficial in the management of Lipoedema
Device Description
Amputee Garment for use with Lympha Press Optimal Plus
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K Number
K190493Device Name
Recovery Pump, 737R (RPX)
Manufacturer
Mego Afek AC Ltd.
Date Cleared
2019-05-15
(76 days)
Product Code
IRP
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
Mego Afek AC Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Recovery Pump is an air compression therapy device intended to provide graduated pressure to compression garments. The Recovery Pump is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. The Recovery Pump simulates kneading and stroking of tissues by using an inflatable garment.
Device Description
The Recovery Pump is an air compression therapy device intended to provide graduated pressure to compression garments.
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K Number
K190015Device Name
Ballancer Gold, 1212
Manufacturer
Mego Afek AC Ltd.
Date Cleared
2019-03-25
(81 days)
Product Code
IRP
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
Mego Afek AC Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ballancer® Gold is a pneumatic massage system intended to provide gradient pressure in areas to which the inflatable garment is applied.
The Ballancer Gold is indicated for:
- · Simulate kneading and stroking of the tissues by use of an inflatable garment.
- · Temporary increase circulation in the areas which the garment is applied
- · Temporary relief of minor muscle aches and pains
Device Description
Ballancer® Gold, Model 1212 is a pneumatic massage system.
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K Number
K182003Device Name
Lympha Press Optimal Plus
Manufacturer
Mego Afek AC Ltd.
Date Cleared
2019-02-27
(216 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Mego Afek AC Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as:
- Primary lymphedema
- · Secondary lymphedema
- · Venous insufficiency
- · Venous stasis ulcers
- · Dysfunction of the muscle pump
- · Post mastectomy edema
- · Edema following trauma and sports issues
- · Post immobilization edema
- · Reducing wound healing time
- · Reduction of pain and swelling after injury and surgery
- · The device may also be beneficial in the management of Lipoedema
The device is intended for hospital, home, and clinic use.
Device Description
Not Found
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K Number
K172277Device Name
Phlebo Press DVT Model
Manufacturer
Mego Afek AC Ltd.
Date Cleared
2017-11-03
(98 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Mego Afek AC Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Phlebo Press DVT Model 760D including compression garments is intended for use by healthcare professionals, and patients who are under medical supervision, in treating conditions such as:
- · Prevention of deep vein thrombosis (DVT) in patients who may be susceptible
- · Reduction of pain and swelling after injury and surgery
- · Enhancement of venous circulation
- · Prevention of venous stasis
- · Assistance in healing of cutaneous ulcers
- · Reducing edema
- · Treatment of chronic venous insufficiency
The device is intended for hospital, home and clinic use
Device Description
Not Found
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K Number
K170658Device Name
Lympha Press Optimal Plus
Manufacturer
Mego Afek AC Ltd.
Date Cleared
2017-05-31
(89 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Mego Afek AC Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for use by medical professionals, and patients who are under medical supervision, in treating many conditions such as:
- Primary lymphedema
- Secondary lymphedema
- · Venous insufficiency
- Venous stasis ulcers
- · Dysfunction of the muscle pump
- Post mastectomy edema
- · Edema following trauma and sports issues
- · Post immobilization edema
- · Reduction of wound healing time
- · Reduction of pain and swelling after injury and surgery
- · The device may also be beneficial in the management of Lipoedema
The device is intended for hospital, home, and clinic use.
Device Description
Lympha Press Optimal Plus Model 912
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K Number
K163280Device Name
RP Lite 760R
Manufacturer
Mego Afek AC Ltd.
Date Cleared
2017-01-27
(67 days)
Product Code
IRP
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
Mego Afek AC Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RP Lite 760R is indicated for the temporary relief of minor muscle aches and for temporary increase in blood circulation to the treated areas in people who are in good health.
The RP Lite 760R simulates kneading and stroking of tissues by using an inflatable garment.
Device Description
Not Found
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K Number
K150269Device Name
Ballancer 505 System, Model 1201-AC
Manufacturer
Mego Afek AC Ltd.
Date Cleared
2015-05-26
(111 days)
Product Code
IRP
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
Mego Afek AC Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Ballancer 505 is a pneumatic massage system intended to provide gradient pressure in areas, which the inflatable garment is applied.
The Ballancer 505 System is indicated for:
* Simulating kneading and stroking of the tissues by use of an inflatable garment
* Temporary increase circulation in areas which the garment is applied
* Temporary relief of minor muscle aches and pains
Device Description
Ballancer® 505 System, Model 1201-AC is a pneumatic massage system.
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K Number
K142772Device Name
Phlebo Press DVT 603
Manufacturer
Mego Afek AC Ltd.
Date Cleared
2014-12-16
(82 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Mego Afek AC Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Phlebo Press DVT 603 is intended for use by medical professionals and patients who are under medical supervision, in treating conditions such as:
- Prevention of deep vein thrombosis (DVT) in patients who may be susceptible
- Reduction of pain and swelling after injury and surgery
- Enhancement of venous circulation
- Prevention of venous stasis
- Assistance in healing of cutaneous ulcers
- Reduction of compartmental pressures
The device is intended for hospital, home and clinic use
Device Description
Not Found
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K Number
K140519Device Name
RECOVERY PUMP 737R
Manufacturer
MEGO AFEK AC LTD
Date Cleared
2014-06-16
(108 days)
Product Code
IRP
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
MEGO AFEK AC LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Recovery Pump 737R is an air compression therapy device intended to provide graduated pressure to compression gaments. The Recovery Pump 737R is indicated for the temporary relief of minor muscle aches and pains, and for temporary increase in blood circulation to the treated areas in people who are in good health. The Recovery Pump 737R simulates kneading of tissues by using an inflatable garment.
Device Description
The Recovery Pump 737R is an air compression therapy device intended to provide graduated pressure to compression gaments. The Recovery Pump 737R simulates kneading of tissues by using an inflatable garment.
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