Heart*aid 1000

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

510(k) Number

K870622 ↗

FDA Product Code

MKJ

Device Class

Class III

Regulation

21 CFR Part 870.5310

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

• Pace Aid

  Not classified

  FDA 510(k) K811028 Active Cleared 16 Apr 1981

• Modified Pace*aid Model 53

  Class II

  FDA 510(k) K871971 Active Cleared 24 Jun 1987

See all devices from Cardiac Resucitator Corp. →

• What is the primary purpose of the HeartAid 1000 in emergency situations?

  The HeartAid 1000 is an Automated External Defibrillator (Non-Wearable) designed to deliver electrical shocks to restore a normal heart rhythm in patients experiencing sudden cardiac arrest. It also includes monitoring functions to assess heart rhythm and guide rescue efforts during emergencies, making it ideal for pre-hospital and emergency settings.

• Is the HeartAid 1000 intended for reuse, or is it meant to be used only once?

  The HeartAid 1000 is explicitly designed for single-use only, ensuring reliability and safety in emergency situations where repeat use could compromise performance or hygiene.

• How is the HeartAid 1000 supplied, and what should I expect in the packaging?

  The HeartAid 1000 is supplied as a portable, pre-hospital emergency unit, ready for immediate deployment. Since it is single-use, the packaging likely includes the defibrillator itself along with any necessary accessories (e.g., electrodes or pads) for a complete emergency response kit.

• Does the HeartAid 1000 require sterilization before use, and if not, how is it maintained?

  The HeartAid 1000 does not require sterilization as it is intended for single-use in emergency settings. Because it is not reusable, maintenance is not applicable—each unit is designed for one-time deployment to ensure reliability and safety.

• What regulatory pathway was followed for the HeartAid 1000’s FDA clearance, and what does this mean for its use?

  The HeartAid 1000 was cleared through an FDA 510(k) process (K870622) under a *Traditional* clearance type, meaning it was determined to be *Substantially Equivalent* to a legally marketed device. This clearance confirms its compliance with FDA standards for Automated External Defibrillators (Non-Wearable) and ensures it meets safety and performance requirements for emergency cardiac use.