(16 days)
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
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.
I'm sorry, but this document does not contain the information requested. The document is a 510(k) summary for the Flexitouch® System, a powered inflatable tube massager. It primarily focuses on demonstrating substantial equivalence to predicate devices for expanding its indications for use.
The document does not include:
- A table of acceptance criteria and reported device performance.
- Details of any specific study (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods) used to prove the device meets acceptance criteria.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or standalone algorithm performance.
- Sample sizes for training and test sets.
§ 870.5800 Compressible limb sleeve.
(a)
Identification. A compressible limb sleeve is a device that is used to prevent pooling of blood in a limb by inflating periodically a sleeve around the limb.(b)
Classification. Class II (performance standards).