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510(k) Data Aggregation
K Number
K153311Device Name
Flexitouch System
Manufacturer
TACTILE SYSTEMS TECHNOLOGY INC (DBA TACTILE MEDICAL)
Date Cleared
2016-09-14
(302 days)
Product Code
PPS, JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
TACTILE SYSTEMS TECHNOLOGY INC (DBA TACTILE MEDICAL)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexitouch® system and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions such as:
- Lymphedema
- Primary lymphedema
- · Post mastectomy edema
- · Edema following trauma and sports injuries
- · Post immobilization edema
- · Venous insufficiencies
- · Reducing wound healing time
· Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers
The Flexitouch® system and garments for the head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema.
Device Description
The Flexitouch® system consists of two main components: a garment set and a pneumatic sequential controller. The garments are wrapped around an affected region so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide for low-level compression therapy. Up to four (4) tubing harness assemblies containing eight (8) discrete individual air passage tubes connect individual garment chambers with the controller.
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K Number
K143185Device Name
entré Model PD08-U
Manufacturer
TACTILE SYSTEMS TECHNOLOGY INC
Date Cleared
2015-05-07
(183 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
TACTILE SYSTEMS TECHNOLOGY INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The entré System is intended for use by medical professionals and patients who are under medical supervision, for the treatment of the following conditions:
- · Chronic edema
- · Lymphedema
- · Venous insufficiency
- · Wound healing
Device Description
The entré model PD08-U system consists of two main components: A controller and a garment. The garment is to be wrapped around the affected extremity providing a snug yet comfortable fit. The garment will have eight (8) chambers that are filled with air by the controller to provide compression on the extremity. A harness assembly consisting of eight (8) individual tubes will connect individual chambers with the controller. The controller has an internal valve manifold with a directly connected single eight (8) port connector extension that is accessible to the user on the front panel allowing easy garment connection.
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K Number
K131193Device Name
ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM
Manufacturer
TACTILE SYSTEMS TECHNOLOGY INC
Date Cleared
2013-06-18
(53 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
TACTILE SYSTEMS TECHNOLOGY INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ACTitouch™ Adaptive Compression Therapy system provides graduated compression in both sustained and intermittent settings for use in:
- Enhancing venous return .
- . Reducing venous leg ulcer healing time
- . Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers
- Treatment of chronic venous insufficiency .
- Reducing edema due to venous stasis
- Treatment of lymphedema
Device Description
The ACTitouch™ System applies compression to the leg (lower leg, ankle, and foot). It consists of four main parts:
- . The Compression Sleeve consists of four chambers that inflate with air to apply pressure to the leg. It's simple wrap-around design with hook and loop fasteners means the Compression Sleeve can be fitted to many differently shaped legs and can be applied and removed with ease.
- The Control Unit fits into the Compression Sleeve during device use. It monitors and . adjusts the air pressure to ensure the correct level of compression is applied to the leg.
- . The Undersock is designed to draw perspiration and moisture away from the skin and has padding in key areas to provide additional comfort.
- . The Power Adapter/Charger is used to power the device directly or to charge the battery for ambulatory use.
The device has two modes of operation: Sustained Compression Mode and Intermittent Pneumatic Compression Mode. Sustained Compression Mode enables the Control Unit to provide accurate and continuously monitored compression levels to the lower limb. Intermittent Pneumatic Compression Mode enables a programmed sequence of cyclical pressures to be applied to the lower limb.
The ACTitouch™ system features a compliance monitoring feature. An LCD screen is present on the Control Unit, which displays the number of hours the device has been operational in both Sustained Compression Mode and Intermittent Pneumatic Compression Mode.
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K Number
K120972Device Name
FLEXITOUCH SYSTEM
Manufacturer
TACTILE SYSTEMS TECHNOLOGY INC
Date Cleared
2012-04-13
(11 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
TACTILE SYSTEMS TECHNOLOGY INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexitouch® system is intended for use by medical professionals and patients at home who are under medical supervision in treating many conditions such as:
- Primary lymphedema .
- Post mastectomy edema .
- Edema following trauma and sports issues .
- Post immobilization edema .
- Venous insufficiencies .
- Lymphedema .
- . Reducing wound healing time
- Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; . arterial and diabetic leg ulcers
Device Description
The Flexitouch® system is a prescription pneumatic compression system consisting of a garment set and a pneumatic sequential controller. The garments are wrapped around the affected body regions so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide for low-level compression in the treated areas.
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K Number
K062818Device Name
FLEXITOUCH SYSTEM
Manufacturer
TACTILE SYSTEMS TECHNOLOGY INC
Date Cleared
2006-10-06
(16 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
TACTILE SYSTEMS TECHNOLOGY INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexitouch system is intended for use by medical professionals and patients who are under medical supervision, in treating many conditions such as:
- . Primary lymphedema
- Post mastectomy edema .
- . Edema following trauma and sports injuries
- . Post immobilization edema
- . Venous insufficiencies
- . Lymphedema.
- Reducing wound healing time .
- . Treatment and assistance in healing: stasis dermatitis; venous stasis ulcers; arterial and diabetic leg ulcers
Device Description
The Flexitouch® System is a powered inflatable tube massager intended for medical purposes. The primary components of the System include a pneumatic sequential controller device that delivers air to garments with inflatable chambers to be worn over the patient's afflicted areas. The inflation and deflation of the chambers simulates kneading and stroking of the tissues with the hands in order to increase circulation.
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K Number
K013061Device Name
BIOTOUCH MASSAGE THERAPY SYSTEM
Manufacturer
TACTILE SYSTEMS TECHNOLOGY INC
Date Cleared
2002-07-01
(293 days)
Product Code
IRP
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
TACTILE SYSTEMS TECHNOLOGY INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The biotouch™ device is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as:
- Primary lymphedema
- Post mastectomy edema
- Edema following trauma and sport injuries
- Post immobilization edema
- Venous insufficiencies
- · Lymphedema.
Device Description
The TSTI biotouch™ device is a microprocessor controlled pneumatic compression device that applies calibrated sequentially graduated pressure to the arm, leg, trunk, and/or chest. The device consists of two major components:
- lightweight, portable pneumatic controller, and .
- extremity garments composed of 4 to 16 chambers. .
The controller is pre-programmed with thirteen separate treatment programs. which consists of pre-determined sequences and inflation times and should be used under medical supervision. The device is provided to the end-user in individual cartons to ensure safe shipping and arrival of the device.
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