Pace Aid Model 53

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

510(k) Number

K844811 ↗

FDA Product Code

DRO

Device Class

Class II

Regulation

21 CFR Part 870.5550

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modified Heart*aid 97 Auto. External Defibrillator

  Class II

  FDA 510(k) K871569 Active Cleared 8 Jun 1987

• Pace* Aid Model 50

  Class II

  FDA 510(k) K820507 Active Cleared 6 Aug 1982

• Pace*aid 10 a -Pad 10A- Pacemaker Output Display &

  Class II

  FDA 510(k) K850596 Active Cleared 6 Mar 1985

• Heart Aid Model 97

  Class II

  FDA 510(k) K850170 Active Cleared 14 Feb 1985

• Heart*aid 1000

  Class III

  FDA 510(k) K870622 Active Cleared 10 Apr 1987

• Pace Aid

  Not classified

  FDA 510(k) K811028 Active Cleared 16 Apr 1981

See all devices from Cardiac Resucitator Corp. →

• What clinical scenarios is the Pace Aid Model 53 intended for, and how does it differ from permanent pacing solutions?

  The Pace Aid Model 53 is designed for emergency and short-term cardiac support when a patient’s natural heart rhythm fails, such as in cases of severe bradycardia or conduction block. Unlike permanent pacemakers, it is non-invasive, delivering electrical impulses through adhesive electrodes on the chest to stimulate the heart temporarily. It is specifically intended for settings like hospital emergency rooms, pre-hospital care, or cardiac care units where internal pacing isn’t immediately feasible. It is not meant for long-term use or as a standalone solution for chronic heart conditions.

• Is the Pace Aid Model 53 single-use or reusable, and what maintenance does it require between patients?

  The Pace Aid Model 53 is a reusable device, not intended for single-use. After each use, it requires cleaning and maintenance to ensure proper function and hygiene for subsequent patients. Since it is not sterile, reprocessing protocols must follow manufacturer guidelines to prevent contamination and maintain performance.

• Where can this device legally be used, and what regulatory approvals does it hold?

  The Pace Aid Model 53 is FDA-cleared under a 510(k) submission (K844811) and classified as a Class II medical device, regulated under 21 CFR 870.5550. It is intended for use in hospital emergency rooms, pre-hospital settings, and cardiac care units in the U.S. The clearance establishes its substantial equivalence to prior-generation external pacemakers, ensuring it meets traditional transcutaneous pacing standards.

• Does the Pace Aid Model 53 come with specific electrode sizes or configurations, and how are they applied?

  The device specifications do not detail electrode sizes or configurations in the provided data, but as a transcutaneous pacemaker, it relies on adhesive electrodes placed on the patient’s chest to deliver stimulation. The exact placement (e.g., V1/V6 or other leads) would follow standard emergency cardiac pacing protocols, typically guided by clinical training and institutional guidelines. The manufacturer’s instructions would outline proper application techniques.

• Are there any restrictions on storage or environmental conditions for the Pace Aid Model 53?

  The provided data does not specify storage requirements beyond standard medical device handling. However, as a reusable device, it should be stored in a clean, dry environment to prevent damage or contamination between uses. Since it is not sterile, it should not be exposed to conditions that could compromise its functionality or hygiene, such as extreme temperatures or humidity.