Search Results
Found 4 results
510(k) Data Aggregation
K Number
K234155Device Name
Nimbl (model PD08-N1)
Manufacturer
Tactile Medical
Date Cleared
2024-06-21
(175 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
Tactile Medical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nimbl 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 Nimbl system is a pneumatic compression device that delivers intermittent sequential compression treatment to affected extremities for lymphedema, chronic edema, venous insufficiency, and wound healing. This device helps direct and move excess fluid from an impaired lymphatic region to healthy regions, where fluid can be absorbed and processed naturally by the body. The Nimbl controller is used to inflate the connected garment chambers in a pre-programmed sequence from the distal end to the proximal end of the patient. The pressure gradient provides higher distal pressures. This creates a dynamic wave of therapy that directs fluid into the lymphatic capillaries while maintaining distal prevent distal backflow. The patient's healthcare provider determines what pressure setting is appropriate for the patient.
Ask a Question
K Number
K203178Device Name
Flexitouch Plus System
Manufacturer
Tactile Systems Technology, Inc. (DBA Tactile Medical)
Date Cleared
2020-12-20
(55 days)
Product Code
JOW, PPS
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
(DBA Tactile Medical)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexitouch Plus Systems and garments for legs, arms, trunk, and chest are intended for use by medical professionals and patients who are under medical supervision to increase lymphatic flow in the treatment of many conditions such as
- Lymphedema
- Primary lymphedema
- Post mastectomy edema
- Edema following trauma and sports injuries
- Post immobilization edema
- Venous insufficiency
- Reducing wound healing time
- Treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers
- Lipedema
- Phlebolymphedema
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 Plus System is an advanced pneumatic compression device clinically proven to stimulate the lymphatic system. The device helps direct and move excess fluid from an impaired lymphatic region to healthy regions, where fluid can be absorbed and processed naturally by your body. Flexitouch Plus garment chambers inflate sequentially with each chamber inflating before the adjacent distal chamber fully deflates. This creates a dynamic wave of therapy that directs fluid into the lymphatic capillaries while maintaining distal pressure to prevent distal backflow.
Ask a Question
K Number
K170216Device Name
Flexitouch System
Manufacturer
Tactile Systems Technology, Inc (dba Tactile Medical)
Date Cleared
2017-05-26
(122 days)
Product Code
JOW, PPS
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 insufficiency
- · 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 affected region so that the garment fits snugly. The garments have multiple chambers that are filled with air to provide pneumatic compression therapy. Up to four (4) tubing harness assemblies containing eight (8) discrete individual air passage tubes connect individual garment chambers with the controller. Air passes through the tubes, delivering treatment via the sequential inflation of up to 32 air chambers in the garments.
Ask a Question
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.
Ask a Question
Page 1 of 1