Siemens Model 146-146A External Pulse G
by Cynergy 510(k)
Active
510(k) K810566
Overview
The Siemens Model 146-146A External Pulse G is an external pulse generator, classified as a pacemaker device. It delivers periodic electrical pulses to stimulate the heart externally, serving as a temporary pacing solution or for managing cardiac arrhythmias when internal pacing is not feasible. Designed for use outside the body, it provides emergency pacing support until a permanent pacemaker can be implanted or to stabilize irregular heart rhythms in acute settings.
This device is supplied as a Class II medical device under FDA 510(k) clearance (K810566) and falls under regulation 870.3600. It is intended for single-use or temporary use in cardiovascular applications, with no indication of sterility or MRI safety in the available data. The device is regulated for external cardiac stimulation and requires prescription use, adhering to traditional 510(k) clearance standards as determined by the Cardiovascular Advisory Committee.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK810566 | Date1 Apr 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DTE
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3600
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Cynergy
Questions
What is the Siemens Model 146-146A External Pulse G used for?
The Siemens Model 146-146A External Pulse G is designed as an external pulse generator to provide temporary cardiac pacing. It delivers periodic electrical pulses externally to stimulate the heart when internal pacing is not feasible, such as in emergency situations or during pre-implant stabilization for patients with acute arrhythmias or unstable heart rhythms.
Is the Siemens Model 146-146A External Pulse G intended for single-use or reusable applications?
The Siemens Model 146-146A External Pulse G is classified for single-use or temporary use in cardiovascular applications. This designation aligns with its purpose as an emergency or interim pacing solution, ensuring patient safety and sterility for acute clinical scenarios.
What regulatory approval does the Siemens Model 146-146A External Pulse G hold?
The Siemens Model 146-146A External Pulse G is cleared under the FDA’s 510(k) pathway (K810566) as a Class II medical device, regulated under 870.3600. It was determined substantially equivalent to a predicate device by the Cardiovascular Advisory Committee in 1981, adhering to traditional clearance standards for external cardiac stimulation.
Does the Siemens Model 146-146A External Pulse G require prescription use?
Yes, the Siemens Model 146-146A External Pulse G is intended for prescription use only. Its classification as a medical device for external cardiac pacing necessitates clinical oversight to ensure appropriate application in acute or temporary pacing scenarios.
What are the key specifications or distinctions of the Siemens Model 146-146A External Pulse G?
The Siemens Model 146-146A External Pulse G is specifically designed as an external pulse generator, distinct from internal pacemakers. It operates outside the body to deliver emergency pacing support, with no explicit indication of sterility or MRI safety in the available data. Its regulatory filing (K810566) and classification under 870.3600 reflect its role in temporary cardiac stabilization.