Ipc-Boot
by C-Boot, Ltd. 510(k)
Active
510(k) K070324
Overview
The Ipc-Boot is a compressible limb sleeve designed for intermittent pneumatic compression of the lower extremity. It consists of an inflatable boot that extends from the patient's foot up to the knee and provides intermittent compression to promote venous return.
The system includes an external electric pump that inflates the sleeve via a control system to deliver the prescribed compression cycles. It is classified as a Class II device (product code JOW) and cleared under FDA 510(k) (K070324) in accordance with 21 CFR 870.5800. The device is supplied as a complete kit with the boot and pump and is intended for use in a clinical setting.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK070324 | Date3 May 2007 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JOW
- FDA applicant
- C-Boot , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5800
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent