(216 days)
The proposed device is to be used to improve the return circulation of body fluid that has pooled in one or more of a patient's extremities. This treatment reduces debilitating pain, swelling, ulceration, and risk of dermatological impact, infection, and amputation.
This is an electromechanical pneumatic device that employs a compressor and precision timer, regulator, and gage to sequentially inflate a sleeve appliance that fits over the patient's extremity. The device is approximately 8"W x 6.75"H x 5.5"D and weighs less than 15 lbs.
The prompt asks to describe the acceptance criteria and the study that proves the device meets them, based on the provided text. However, the provided text describes a "Wright Linear Pump" which is a sequential compression pump, not an AI/ML powered medical device. Therefore, many of the requested fields are not applicable to the given text.
Here's an analysis based on the provided information, noting where sections are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicit or Implied) | Reported Device Performance |
|---|---|
| Functional / Performance: | |
| Produces sequential compression | Produces sequential compression |
| Max pressure |
§ 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).