# K070324: Ipc-Boot

- Pathway: 510(k) (Special)
- Applicant: C-Boot, Ltd.
- Decided: May 3, 2007 after 87 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: 2 generations back to K810338 (1981). 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)
- K041659: C-BOOT, C-Boot, Ltd. (2004) Summary page 2.

## Indications for use
The IPC-Boot is a prescriptive device that induces controlled compression of the calf, the foot or a combined compression of both. The IPC-Boot 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/K070324
Methodology: https://510kreport.com/methodology