Heart Aid Model 97

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

510(k) Number

K850170 ↗

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 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

• 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 Heart Aid Model 97 used for?

  The Heart Aid Model 97 is an external transcutaneous (non-invasive) cardiac pacemaker designed to provide temporary pacing stimulation to the heart. It is specifically intended for emergency cardiac pacing scenarios where internal pacing is not feasible or available, helping to maintain cardiac rhythm and support circulation during critical situations in settings like emergency rooms, pre-hospital environments, or cardiac care units.

• Is the Heart Aid Model 97 single-use or reusable?

  The Heart Aid Model 97 is supplied as a reusable medical instrument. It is not sterile and requires proper cleaning and maintenance between uses to ensure safe and effective operation. Regular maintenance is essential to comply with clinical protocols and regulatory requirements.

• What regulatory pathway does the Heart Aid Model 97 follow?

  The Heart Aid Model 97 is regulated under the FDA’s Traditional 510(k) pathway and holds clearance K850170. It is classified as a Class II Cardiovascular device under FDA product code DRO, with a decision of Substantially Equivalent (SESE) by the Cardiovascular Advisory Committee. This clearance confirms its equivalence to a predicate device and compliance with FDA standards for external transcutaneous pacemakers.

• How should the Heart Aid Model 97 be stored?

  While the device is reusable, it is not sterile and must be cleaned and maintained between uses. Storage should follow manufacturer guidelines to prevent contamination and ensure proper functionality. Specific storage conditions, such as temperature or humidity, are not detailed in the provided data, but standard clinical protocols for reusable medical devices should be followed.

• Does the Heart Aid Model 97 have any MRI safety information?

  The available data for the Heart Aid Model 97 does not provide any specific MRI safety information. Clinicians should exercise caution when using or storing the device near MRI equipment, as external transcutaneous pacemakers may interact with magnetic fields. Always consult the manufacturer’s instructions or local protocols for MRI-safe handling.