Stony Brook Model EECP-MC1
by Stony Brook Trading and Development Corp.
510(k) K882401
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK882401 | Date3 Mar 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 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- Withdrawn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, 1 Oct 2026
The Stony Brook Model EECP-MC1 is an External Counter-Pulsating Device, classified under FDA product code DRN (Device, Counter-Pulsating, External). This device is designed to augment peripheral blood flow by inflating and deflating cuffs wrapped around the legs, mimicking the natural pulse to improve circulation and reduce symptoms of peripheral artery disease or congestive heart failure.
The Model EECP-MC1 is intended for use in clinical settings, supplied as a reusable medical device under 21 CFR 870.5225. It requires proper training for operation and maintenance, with cuff sizes tailored to patient limb dimensions. The device received FDA 510(k) clearance (K882401) in 1989 under the Cardiovascular advisory committee, classified as substantially equivalent (SESE) to predicate devices. No third-party certification is indicated in the regulatory records.
Questions
AI-generated answers, 1 Oct 2026
What is the Stony Brook Model EECP-MC1 used for?
The Stony Brook Model EECP-MC1 is designed to augment peripheral blood flow by mimicking the natural pulse through controlled inflation and deflation of leg cuffs. This helps improve circulation and reduce symptoms associated with peripheral artery disease or congestive heart failure. The device achieves this by enhancing arterial blood flow during diastole, thereby supporting cardiac function and reducing reliance on medications for symptom management.
Is the Stony Brook Model EECP-MC1 reusable or single-use?
The Stony Brook Model EECP-MC1 is classified as a reusable medical device under 21 CFR 870.5225. This means it is intended for repeated use in clinical settings, provided it undergoes proper maintenance, cleaning, and sterilization protocols as outlined in the manufacturer’s instructions. Reusability is contingent on adherence to operational guidelines to ensure patient safety and device efficacy.
What cuff sizes are available for the Stony Brook Model EECP-MC1?
The cuff sizes for the Stony Brook Model EECP-MC1 are tailored to accommodate varying patient limb dimensions. While exact sizing details are not specified in the provided data, the device is designed to fit standard leg measurements, ensuring proper inflation and deflation coverage. Clinicians should refer to the manufacturer’s documentation for precise sizing charts and application instructions to select the appropriate cuff size for each patient.
What training is required to operate the Stony Brook Model EECP-MC1?
The Stony Brook Model EECP-MC1 is intended for use in clinical settings and requires proper training for both operation and maintenance. This ensures operators understand the device’s functionality, patient application techniques, and maintenance protocols to prevent malfunctions or patient harm. Training typically includes hands-on instruction, troubleshooting guidance, and familiarity with the device’s controls and cuff systems.
How was the Stony Brook Model EECP-MC1 approved by the FDA?
The Stony Brook Model EECP-MC1 received FDA 510(k) clearance (K882401) in 1989 under the Cardiovascular advisory committee. The device was classified as substantially equivalent (SESE) to predicate external counter-pulsating devices, meaning it was determined to have the same intended use, technological characteristics, and performance as legally marketed competitors. The clearance process involved demonstrating equivalence to existing approved devices rather than requiring new clinical trials.