Nicore Model NCP-1 External Counterpulsation Device
by Nicore Equipment & Leasing, Inc.
510(k) K023016
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023016 | Date4 Dec 2002 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DRN
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5225
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 20 Sep 2026
The Nicore Model NCP-1 External Counterpulsation Device is a Device, Counter-Pulsating, External, designed to augment cardiac function by synchronizing external compression and decompression of the lower limbs with the cardiac cycle. It operates to improve coronary and peripheral blood flow, supporting patients with cardiovascular conditions by reducing myocardial oxygen demand and enhancing perfusion during diastole.
This device is intended for use in clinical settings, typically under medical supervision, and is supplied as a reusable system requiring proper maintenance and calibration. It is classified as a Class II medical device under FDA regulations (21 CFR 870.5225) and holds a FDA 510(k) clearance (K023016) with substantial equivalence to prior-authorized devices. No specific sterility or single-use designation is stated in the regulatory data.
Other devices from Nicore Equipment & Leasing, Inc.
Questions
AI-generated answers, 20 Sep 2026
What is the primary purpose of the Nicore Model NCP-1 External Counterpulsation Device, and how does it work?
The Nicore Model NCP-1 is designed to improve cardiac function by applying synchronized external compression and decompression to the lower limbs, timed with the patient’s cardiac cycle. This technique enhances coronary and peripheral blood flow, reduces myocardial oxygen demand, and increases perfusion during diastole—helping patients with cardiovascular conditions by supporting circulation without invasive procedures.
Is the Nicore Model NCP-1 meant for single-use or reusable applications, and what maintenance is required?
The device is explicitly labeled as a reusable system, requiring proper maintenance and calibration to ensure safety and performance. Since it is not designated sterile or single-use, facilities must follow manufacturer guidelines for cleaning, disinfection, and periodic servicing to maintain regulatory compliance and clinical efficacy.
How is the Nicore Model NCP-1 regulated, and what does its FDA clearance indicate?
The device holds a FDA 510(k) clearance (K023016), classified under Class II (21 CFR 870.5225) with substantial equivalence to prior-authorized external counterpulsation devices. This clearance confirms it meets FDA standards for safety and effectiveness as a non-invasive cardiovascular support tool, though it does not imply approval for specific clinical indications beyond its labeled use.
What types of cardiovascular patients might benefit from this device, and where is it typically used?
While the device is not intended for any specific diagnosis, it is primarily used in clinical settings (e.g., hospitals or specialized cardiac centers) to support patients with chronic cardiovascular conditions where improved perfusion and reduced myocardial stress are clinically relevant. Usage is typically supervised by medical professionals as part of a broader treatment plan.
Are there different sizes or models of the Nicore Model NCP-1, or is it a single-device solution?
The provided data does not specify multiple sizes or models for the NCP-1. It is described as a singular external counterpulsation device, implying a standardized design for lower-limb compression. However, patient-specific fit (e.g., cuff sizing) may still require adjustment based on clinical needs, though this is not detailed in the regulatory submission.