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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?
Product Code :
PPS
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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