Pulse Generator Model 61 and 128

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K790562 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pacing Lead #PMA F 860

  Class III

  FDA 510(k) K830457 Active Cleared 17 Mar 1983

• Opus Pulse Generators Models 2001, 2003, and 2004

  Class III

  FDA 510(k) K882474 Active Cleared 12 Sep 1988

• Lead Models MUM 1260, MUM 1290

  Class III

  FDA 510(k) K790386 Active Cleared 3 Apr 1979

• Focus J81F, J83F, J41F, J43F Pacing Leads

  Class III

  FDA 510(k) K896742 Active Cleared 17 Jul 1990

• Focus T41, T41F, T43, T43F, T44F

  Class III

  FDA 510(k) K904255 Active Cleared 18 Jan 1991

• Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)

  Class III

  FDA 510(k) K952364 Active Cleared 1 Sep 1995

See all devices from Ela Medical, Inc. →

• What is the primary purpose of the Pulse Generator Model 61 and 128 in a pacemaker system?

  The Pulse Generator Model 61 and 128 serves as the power source and control unit for pacemaker systems, delivering electrical impulses to regulate abnormal heart rhythms. It is specifically designed for patients with bradycardia or conduction disorders to maintain proper cardiac function by ensuring consistent pacing signals.

• How is the Pulse Generator Model 61 and 128 supplied, and is it intended for single-use or reuse?

  The Pulse Generator Model 61 and 128 is supplied as a reusable component in a sterile package, intended for single-patient application upon receipt. Sterility is maintained for implantation, but the device itself is not single-use—it is designed to remain implanted in the patient long-term.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The Pulse Generator Model 61 and 128 received FDA clearance under the Traditional 510(k) review pathway (K790562) with a decision of Substantially Equivalent (SESE). This means the FDA determined it is as safe and effective as a legally marketed predicate device, allowing it to be marketed for its intended use in regulating abnormal heart rhythms via electrical pacing.

• Are there specific storage or handling requirements for this device before implantation?

  Yes, the Pulse Generator Model 61 and 128 must be stored and handled according to sterile medical device protocols to preserve its integrity before implantation. Since it is supplied sterile, adherence to these protocols ensures the device remains uncontaminated and ready for use in cardiovascular procedures.

• What medical specialty is primarily responsible for the use of this device, and how does that relate to its design?

  The Pulse Generator Model 61 and 128 falls under the Cardiovascular medical specialty, as indicated in the regulatory records. This aligns with its design as an Implantable Pacemaker Pulse-Generator, which is intended for use by cardiologists or electrophysiologists to treat patients with bradycardia or conduction disorders requiring consistent cardiac pacing.