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Sign in to claim this brandCardio Command
US
Last updated May 23, 2026
What Cardio Command makes
Cardio Command manufactures medical devices for temporary cardiac pacing and electrocardiographic monitoring, including external pacemakers for transoesophageal pacing, reusable and single-use leads, pacing leads, and adaptors for ECG signal transmission. Their portfolio also includes reusable temporary pacing connection cables and electronic oesophageal stethoscopes designed for clinical use.
The company’s devices are regulated under FDA classifications, with products authorised through Premarket Approval (PMA) and Urgent Device Exemptions (UDE). These devices are listed under Class II and Class III categories, reflecting their intended use in critical cardiac applications, and are based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Cardio Command manufacture?
Cardio Command specializes in devices for temporary cardiac pacing and electrocardiographic monitoring. Their portfolio includes external pacemakers designed for transoesophageal pacing, reusable and single-use leads for ECG signal transmission, adaptors for ECG leads, reusable temporary pacing connection cables, and electronic oesophageal stethoscopes. These devices are primarily used in clinical settings to support cardiac rhythm management and diagnostic monitoring.
Where is Cardio Command based, and how does that affect its regulatory oversight?
Cardio Command is based in the United States, which means its devices fall under FDA regulatory jurisdiction. The FDA classifies their products as either Class II or Class III, depending on their intended use and risk level. Class III devices, such as external pacemakers for transoesophageal pacing, require Premarket Approval (PMA) due to their higher risk, while Class II devices may be authorised through other pathways like Urgent Device Exemptions (UDE).
Which regulatory registries or databases list Cardio Command’s devices?
Cardio Command’s devices are listed in the FDA’s Premarket Approval (PMA) and Urgent Device Exemption (UDE) registries. These registries track devices authorised under specific FDA pathways, ensuring transparency about their regulatory status. The inclusion in these databases reflects the devices’ compliance with FDA requirements for temporary cardiac pacing and electrocardiographic monitoring applications.
How are Cardio Command’s devices classified by the FDA, and why does this matter?
Cardio Command’s devices are classified as either Class II or Class III by the FDA. Class III devices, such as external pacemakers for transoesophageal pacing, are considered higher risk and require Premarket Approval (PMA) to demonstrate safety and effectiveness before market authorisation. Class II devices, like reusable ECG lead sets or adaptors, may undergo less stringent review processes but still require compliance with FDA guidelines to ensure their intended use is met. This classification helps determine the regulatory pathway and scrutiny level for each device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (28)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tapsystem | 2A Patient Cable | FDA UDI | Class III | Active |
| Model 7A | Unpackaged | FDA UDI | Class III | Active |
| Model 7A | Right arm patient lead wire | FDA UDI | Class III | Active |
| Tapsystem | 2A, single pack | FDA UDI | Class III | Active |
| EP-Connect | Octapolar | FDA UDI | Class II | Active |
| Model 3 | Re-manufactured, unpackaged | FDA UDI | Class III | Active |
| Tapscope | 210, single pack | FDA UDI | Class II | Active |
| Model 3 | Re-manufactured, single pack | FDA UDI | Class III | Active |
| Model 3 | Single pack | FDA UDI | Class III | Active |
| Tapsystem | 2A re-man'd, unpackaged | FDA UDI | Class III | Active |
| Model 7A | 7A/Mod 3 Instrument Cable | FDA UDI | Class III | Active |
| Tapcath | 1600, single pack | FDA UDI | Class II | Active |
| Model 7A | Re-manufactured, single pack | FDA UDI | Class III | Active |
| Tapcath | 205, single pack | FDA UDI | Class II | Active |
| Tapsystem | 2A, unpackaged | FDA UDI | Class III | Active |
| Model 7A | Single pack | FDA UDI | Class III | Active |
| Tapscope | 210-S, single pack | FDA UDI | Class II | Active |
| Model 3 | Unpackaged | FDA UDI | Class III | Active |
| Model 7A | 7A/Mod 3 Interface cable | FDA UDI | Class III | Active |
| Tapscope | 550, single pack | FDA UDI | Class II | Active |
| Tapsystem | 2A re-man'd, single pack | FDA UDI | Class III | Active |
| EC-View | ECG adapter | FDA UDI | Class II | Active |
| Tapscope | 550F, single pack | FDA UDI | Class II | Active |
| Model 7A | Re-manufactured, unpackaged | FDA UDI | Class III | Active |
| EP Connect | Tapcath | FDA UDI | Class II | Active |
| Model 7A | Left arm patient lead wire | FDA UDI | Class III | Active |
| Stat-Pace Ii | P840002 | FDA PMA | Class III | Active |
| Arzco Transesophageal Cardiac Stimulator Model 7 | P860008 | FDA PMA | Class III | Active |
Related Companies
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FDA Recalls (5)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
Cardio Command has five recall records initiated between October 27, 2003, and June 24, 2019, all marked as terminated. The reasons cited include potential battery corrosion, assembly errors affecting power switch connections, spurious heart rate increases during simultaneous use with electrosurgical devices, and possible electrical discontinuity in esophageal pacing/recording catheters that could impair pacing and ECG recording.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jun 24, 2019 | Z-1976-2019 | — | terminated | There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly. |
| May 10, 2019 | Z-1773-2019 | — | terminated | Possible corrosion of the battery contact(s). |
| Oct 25, 2010 | Z-0072-2012 | — | terminated | CardioCommand, Inc. is recalling their TAPSCOPE 550 esophageal pacing/recording catheters because there maybe electrical discontinuity, which can result in the inability to reliably pace and/or record ECG. |
| Oct 25, 2010 | Z-0071-2012 | — | terminated | CardioCommand, Inc. is recalling their TAPSCOPE 550 esophageal pacing/recording catheters because there maybe electrical discontinuity, which can result in the inability to reliably pace and/or record ECG. |
| Oct 27, 2003 | Z-0568-04 | — | terminated | The device may exhibit spurious heart rate increase during esophageal atrial pacing during simultaneous adjacent use of electrosurgical coagulation devices. |