# K071763: Amadeus Adaptive Compression Therapy

- Pathway: 510(k) (Traditional)
- Applicant: Convatec
- Decided: Mar 7, 2008 after 252 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
Longest line of descent: 1 generation back to K882683 (1988). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012994: Wizair DVT, Medical Compression Systems (Dbn), Ltd. (2002) Summary page 1.
- K882683: Jobst Extremity Pump (R) System 7500, Jobst Institute, Inc. (1988) Summary page 1.
- K043423: Model SC-3008 Sequential Circulator, Bio Compression Systems, Inc. (2005) Summary page 2.

## Indications for use
Amadeus Adaptive Compression Therapy provides optimized graduated compression in both sustained and intermittent settings for use in: - Enhancing venous return - Reducing venous leg ulcer healing time - Treatment and promotion of healing of stasis dermatitis and venous stasis ulcers - Treatment of chronic venous insufficiency - Reducing edema due to venous stasis

Source page: https://510kreport.com/device/K071763
Methodology: https://510kreport.com/methodology