Disposable Gel Defibrillation/External Pacing Elec
by Medac, Inc.
510(k) K874447
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK874447 | Date27 Jan 1988 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DRO
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5550
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
This device is a Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) as classified by the FDA. It is designed for defibrillation and external transcutaneous pacing, delivering electrical impulses to the heart through gel-coated electrodes to restore normal rhythm or pace the heart when necessary. The electrodes are intended for single-use applications in emergency and clinical settings where rapid intervention is required. Their low-impedance design ensures efficient current flow and reliable performance during critical procedures.
The disposable gel electrodes are supplied sterile and intended for one-time use only, adhering to FDA regulation 870.5550 under product code DRO. They are classified as a Class II device and have received FDA 510(k) clearance (K874447) under the Traditional clearance type. Storage and handling must comply with sterile medical device protocols, and proper disposal follows single-use medical device guidelines. No MRI safety information is specified, and the device is not intended for reusable applications.
Other devices from Medac, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Medac disposable gel defibrillation/external pacing electrode designed for?
This device is designed for defibrillation and external transcutaneous pacing. It delivers electrical impulses to the heart through gel-coated electrodes to restore normal heart rhythm or provide pacing when needed, particularly in emergency or clinical settings where rapid intervention is critical.
How is the Medac disposable gel defibrillation/external pacing electrode supplied and intended for use?
The electrodes are supplied sterile and are intended for single-use applications only. They adhere to FDA regulations under product code DRO (870.5550) and are classified as a Class II medical device, ensuring compliance with sterile medical device protocols for storage and handling.
Why is the low-impedance design important in this device?
The low-impedance design ensures efficient current flow during defibrillation or pacing procedures. This is critical in emergency situations where reliable performance is essential to successfully restore or maintain a normal heart rhythm.
Can the Medac disposable gel defibrillation/external pacing electrode be reused?
No, the device is explicitly intended for single-use only. Reuse is not recommended or approved, as it could compromise sterility, performance, and patient safety. Proper disposal must follow single-use medical device guidelines after one use.
What storage and handling precautions should be taken with these electrodes?
Storage and handling must comply with sterile medical device protocols to maintain sterility. The electrodes should be stored in their original packaging until use and disposed of appropriately after a single application to prevent contamination and ensure safety.