Identifiers
- 510(k) Number
- K072200 FDA 510(k)
- FDA Product Code
- JOQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1750 FDA 510(k)
- Regulation Number
- 870.1750 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The StimLab is a cardiac stimulator device used for electrophysiological studies. It functions as an external programmable pulse generator designed to provide cardiac stimulation in clinical settings.
The StimLab is supplied as a bedside stimulator system with a slave display and touch screen controller for monitoring and adjusting settings. It is a Class II medical device cleared by the FDA under product code JOQ for use in cardiovascular procedures.
Frequently asked questions
What is the STIMLAB device used for?
The STIMLAB is a cardiac stimulator device designed for electrophysiological studies. It functions as an external programmable pulse generator that provides cardiac stimulation in clinical settings, particularly for cardiovascular procedures.
How is the STIMLAB supplied and what are its key features?
The STIMLAB is supplied as a bedside stimulator system with a slave display and touch screen controller. This allows clinicians to monitor and adjust stimulation settings conveniently during procedures.
What is the regulatory classification of the STIMLAB device?
The STIMLAB is a Class II medical device cleared by the FDA under product code JOQ. It received traditional 510(k) clearance with a substantially equivalent determination in 2007 for use in cardiovascular procedures.
Is the STIMLAB designed for single-use or reuse?
The device data does not specify whether the STIMLAB is intended for single-use or multiple reuse. As an external programmable pulse generator for clinical settings, it appears designed for repeated use in a healthcare environment, but specific reuse instructions would be provided in the device's labeling.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: StimLab™ - Micropace EP, StimLab - LinkedIn, MICROPACE STIMLAB USER INSTRUCTION MANUAL Pdf Download, STIMLAB Cardiac Stimulator - Boston Scientific
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K072200 | Class II | Active |
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Manufacturer
- Manufacturer
- Micropace Pty Ltd
- FDA Applicant
- Micropace Pty, Ltd.
Sources (1)
- FDA 510(k) K072200 24 fields · synced Sep 28, 2026