AugEase Vascular Augmentation Device
by Augdvt, LLC 510(k)
Active
510(k) K101355
Overview
The AugEase Vascular Augmentation Device is a sleeve, limb, compressible device designed to generate static tourniquet pressure on extremities. It functions as an accessory to ultrasound imaging systems, with or without Doppler, to assist in vascular testing by inflating and deflating an air bladder cuff via foot actuation. The device is intended for distal, proximal, and reflux augmentations during diagnostic procedures.
This device is supplied as a reusable medical instrument and is classified under FDA regulation 870.5800 as a Class II device. It is intended for use in clinical settings such as vascular laboratories, where it is applied to limbs for controlled pressure augmentation during diagnostic imaging. The device requires proper sterilization and maintenance as per manufacturer guidelines. Its clearance under FDA 510(k) K101355 confirms regulatory compliance for vascular testing applications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK101355 | Date26 Oct 2010 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JOW
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5800
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Questions
What is the AugEase Vascular Augmentation Device used for?
The AugEase Vascular Augmentation Device is designed to assist in vascular testing by generating static tourniquet pressure on extremities. It inflates and deflates an air bladder cuff via foot actuation to enhance ultrasound imaging—with or without Doppler—during distal, proximal, and reflux augmentations. This helps improve diagnostic clarity for procedures in vascular laboratories.
Is the AugEase Device single-use or reusable?
The AugEase Vascular Augmentation Device is classified as a reusable medical instrument. Like other reusable devices, it requires proper sterilization and maintenance as specified by the manufacturer to ensure safety and performance during repeated use in clinical settings.
How is the device activated and controlled?
The device features a foot-actuated mechanism to inflate and deflate the air bladder cuff. This allows clinicians to apply controlled pressure to a limb without needing to manually adjust the cuff, streamlining the diagnostic process during ultrasound imaging.
What regulatory classification does the AugEase Device hold?
The AugEase Vascular Augmentation Device is classified under FDA regulation 870.5800 as a Class II medical device. This classification reflects its intended use in clinical settings for vascular testing, where it must meet specific performance and safety standards.
What types of sterilization does the device require?
Since the AugEase Device is reusable, it must undergo proper sterilization procedures as outlined by the manufacturer to prevent contamination between uses. Common methods for reusable medical devices include autoclaving, ethylene oxide sterilization, or other validated processes to ensure sterility and functionality.