# K012612: Clearmedical/Novamedix Avi Foot Cover, Pair, Regular & Large Size

- Pathway: 510(k) (Traditional)
- Applicant: Clearmedical, Inc.
- Decided: Feb 6, 2002 after 177 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- 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) Novamedix Arterial Venous Impulse (AVI) Foot Covers distributed by Kendall: named in the summary without a submission number

## Indications for use
The A-V Impulse System foot pump is safe and effective for the following indications. The proper duration for use of each indication is subject to the clinical judgment of the prescribing physician. Recommended Guidelines are as follows: Indication Recommended Guidelines Circulation Enhancement For temporary impairments such as temporary trauma or disease conditions, continuous use until the condition is resolved. For chronic impairments, daily use depending on the severity of the patient’s condition and activity. Deep Vein Thrombosis Prophylaxis Continuous use until the patient is fully ambulatory and weight bearing (not just mobilized) Edema — Acute Continuous use until edema is reduced. Indication Recommended Guidelines Edema -- Chronic As required, but at least 4 hours per day. Extremity Pain Incident to Trauma or Surgery Continuous use until severity of pain is reduced or physician recommends alternative therapy. Leg Ulcers Continuous use until ulcer severity is reduced or physician recommends alternative therapy. Venous Stasis/Venous Insufficiency For temporary impairments such as temporary trauma or disease conditions, continuous use until condition is resolved. For chronic impairments, daily use depending on the severity of the patient’s condition and activity level.

Source page: https://510kreport.com/device/K012612
Methodology: https://510kreport.com/methodology