Ultra-Chek Pacemaker Monitor
510(k) K801022
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK801022 | Date17 Jun 1980 | StatusActive |
Recalls
No FDA recalls found in the data synced 5 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KRE
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3640
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Ultra-Chek Pacemaker Monitor is an Analyzer, Pacemaker Generator Function, Indirect, as classified under FDA regulation 870.3640. This electrically powered device evaluates pacemaker function by assessing an implanted pacemaker’s pulse rate and pulse width through noninvasive external electrodes placed on the patient’s skin. It provides periodic monitoring to verify battery status and operational integrity without direct surgical intervention. Designed for cardiovascular applications, it serves as a diagnostic tool to ensure proper pacemaker performance in clinical settings.
The device is supplied as a reusable medical instrument and is intended for use in hospital or clinical environments where pacemaker patients require routine monitoring. It operates under standard electrical safety standards and is not classified as MRI-safe or MRI-conditional. No specific sterility requirements are noted in the regulatory submission, though typical clinical practice would dictate cleaning and disinfection protocols between uses. Authorized under FDA 510(k) clearance K801022 with a decision date of June 17, 1980, the Ultra-Chek Pacemaker Monitor falls under the Cardiovascular advisory committee’s review panel.
Other devices from Powers Medical Systmes
Questions
AI-generated answers, 1 Oct 2026
What is the Ultra-Chek Pacemaker Monitor used for?
The Ultra-Chek Pacemaker Monitor evaluates the function of implanted pacemakers by measuring pulse rate and pulse width through noninvasive external electrodes placed on the patient’s skin. It helps verify battery status and operational integrity, ensuring the pacemaker performs correctly in clinical settings without requiring direct surgical access.
Is the Ultra-Chek Pacemaker Monitor reusable or single-use?
The Ultra-Chek Pacemaker Monitor is designed as a reusable medical instrument. It is intended for use in hospital or clinical environments where multiple patients require routine pacemaker monitoring. Standard cleaning and disinfection protocols should be followed between uses to maintain safety and sterility.
How does the Ultra-Chek Pacemaker Monitor differ from direct pacemaker checks?
Unlike direct methods that require surgical exposure to assess pacemaker function, the Ultra-Chek uses external electrodes placed on the patient’s skin to perform noninvasive monitoring. This allows for periodic checks of pulse rate and battery status without the need for invasive procedures, making it ideal for routine clinical evaluations.
What safety considerations apply to the Ultra-Chek Pacemaker Monitor?
The device operates under standard electrical safety standards but is not classified as MRI-safe or MRI-conditional. Users should follow typical clinical practices for cleaning and disinfection between uses, as no specific sterility requirements are noted in the regulatory submission. Always adhere to manufacturer guidelines for safe operation.
What regulatory approval does the Ultra-Chek Pacemaker Monitor hold?
The Ultra-Chek Pacemaker Monitor holds FDA 510(k) clearance under the classification of an Analyzer, Pacemaker Generator Function, Indirect. It was reviewed by the Cardiovascular Advisory Committee and granted substantial equivalence with clearance number K801022, issued on June 17, 1980.