# K950943: Ultra Ease

- Pathway: 510(k) (Traditional)
- Applicant: Lectec Corp.
- Decided: Mar 7, 1996 after 385 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Aquasonic Ultrasonic Transmission Gel: named in the summary without a submission number
- (no number) Aquaflex Ultrasound Gel Pad: named in the summary without a submission number

## Indications for use
Ultra Ease Ultrasound Gel Pad is indicated for use as an ultrasound transmission gel to be used in conjunction with an Ultrasonic Blood Flow Detector to auscultate peripheral vascular perfusion.

Source page: https://510kreport.com/device/K950943
Methodology: https://510kreport.com/methodology