# K041659: C-BOOT

- Pathway: 510(k) (Traditional)
- Applicant: C-Boot, Ltd.
- Decided: Oct 28, 2004 after 132 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 K810338 (1981). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002287: Wizair Compression System, Medical Compression Systems (Dbn), Ltd. (2000) Summary page 2.
- K810338: Lympha Press, Mego Afek (1981) Summary page 2.

## Most influential descendants
- K070457: Sun Scientific LLC-Leg Compressor and Pfab (2007), 0 descendants of its own
- K070324: Ipc-Boot (2007), 0 descendants of its own

## Indications for use
The C-Boot T M is a prescriptive device that induces controlled compression of the calf, the foot or a combined compression of both. The C-Boot T M is intended to assist patients, suffering from lymphatic or venous disorders, by treating many conditions including: 1. Prevention of deep vein thrombosis (DVT) 2. Enhancement of blood circulation 3. Reduction of post-operative pain and swelling 4. Reduction of wound-healing time 5. Stasis dermatitis 6. Treatment and assist healing of cutaneous ulceration 7. Venous stasis ulcers 8. Leg ulcers 9. Chronic venous insufficiencies 10. Reduction of edema 11. Prevent pooling of fluids in limbs 12. Lymphedema

Source page: https://510kreport.com/device/K041659
Methodology: https://510kreport.com/methodology