(20 days)
TriplePlay Pro (supplied with a pair of model TP-3333, TP-3636, or TP-3434 "cuffs") is indicated for being an easy to use portable system, prescribed by a physician, to help prevent the onset of DVT in patients by stimulating blood flow in the extremeties (simulating muscle contractions). This device can be used to:
- Aid in the prevention of DVT; .
- Enhance blood circulation; .
- Diminish post-operative pain and swelling; ●
- Reduce wound healing time; ●
- Aid in the treatment and healing of stasis dermatitis, venous stasis ulcers, arterial and . diabetic leg ulcers, chronic venous insufficiency and reduction of edema in the lower . limbs:
- As a prophylaxis for DVT by persons expecting to be stationary for long periods of time .
Not Found
This document is a 510(k) clearance letter for a medical device called "TriplePlay Pro," a compressible limb sleeve system. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls of the FDA.
Therefore, I cannot provide the requested information based on the provided text. The document is a regulatory approval, not a technical report detailing performance studies.
§ 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).