Quick facts
- United States: an electrocardiograph has a named entry at 21 CFR 870.2340, described as a device that "processes the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart".
- United States: section 870.2340(b) places the electrocardiograph in Class II (performance standards).
- United States: an electrocardiograph electrode is a separate entry at 21 CFR 870.2360, placed in Class II (special controls) and exempt from premarket notification subject to 870.9, with the special control named as an FDA guidance document.
- Canada: Schedule 1 to the Medical Devices Regulations, SOR/98-282 names no electrocardiograph. A device that records rather than penetrates is reached through the general rules, and an electrode applied to intact skin is a non-invasive device.
- Both countries: the device and its electrodes are classified separately, so a monitor and a box of electrodes are two products in a regulatory file even when they are ordered together.
- The American sections cited here were retrieved 2026-10-03; the Canadian regulation text is current to 2026-09-21.
An ECG is bought as a lead set and used as a signal. The electrodes stick to the chest, the lead wires carry the difference between two of them, and the monitor turns that difference into a trace. In the United States that chain is cut into two named entries, one for the machine and one for the electrode, and the two entries carry different kinds of control. Canada does not cut the chain by name, so a buyer has to know which rule catches each part.
Are the electrocardiograph and its electrodes one device or two?
In the United States they are two, and the difference is visible in the type of control each entry carries.
Section 870.2340 describes the electrocardiograph as the device that processes the signal from "two or more electrocardiograph electrodes" and produces "a visual display of the electrical signal produced by the heart". Its class is Class II, and the control is stated as performance standards.
Section 870.2360 describes the electrode as "the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram". Its class is also Class II, but the control is written differently: special controls, with a premarket notification exemption subject to 870.9, and the special control named as the FDA "Class II Special Controls Guidance Document: Electrocardiograph Electrodes".
That split has a purchasing consequence. A monitor is one file and a box of electrodes is another, and a recall, a specification change or a supplier switch touches only one of them at a time. A clinic that manages the two as a single line loses the ability to answer a traceability question about either.
| Item | Canada | United States |
|---|---|---|
| Named entry for the monitor | None in Schedule 1 | 870.2340, electrocardiograph |
| Named entry for the electrode | None | 870.2360, electrocardiograph electrode |
| Class of the monitor | Reached by the general rules | Class II, performance standards |
| Class of the electrode | Non-invasive device on intact skin | Class II, special controls |
| Premarket notification | A licensing duty at the applicable class | Exempt for the electrode, subject to 870.9 |
Does the American electrode entry name its own special control?
Yes, and that is unusual enough to be worth quoting.
Section 870.2360 states that the special control for the electrode "is the FDA guidance document entitled 'Class II Special Controls Guidance Document: Electrocardiograph Electrodes'". Naming the guidance inside the regulation means the control is a specific document rather than a general expectation, and a supplier that cannot point to the document is not pointing to the special control.
Canada does not name a control for an electrode, because the class is reached through the general rules. An electrode applied to intact skin does not penetrate the body and does not contact the surface of the eye, so it is a non-invasive device, and the general non-invasive rule applies. A device intended for use on compromised skin is described by a different rule, and an electrode sold for that use is not the same device as one sold for a routine resting trace.
For a buyer, the practical reading is that the electrode is a controlled device on both sides of the border, and the American file is the one that names its control. A specification sheet that describes only the adhesive and the gel is describing the product rather than the control.
| Question | Canada | United States |
|---|---|---|
| Is the electrode controlled separately | Yes, by the general rules | Yes, by 870.2360 |
| Control named in the instrument | No | Yes, the FDA guidance document |
| Intact skin electrode | Non-invasive device | Class II special controls |
| Compromised skin electrode | Reached by the rule for injured skin | Described by its own intended use |
| Practical effect | Rule path recorded per product | Guidance named per product |
How many leads does the American definition require?
Two, in the sense that the definition counts electrodes rather than channels.
Section 870.2340 describes the electrocardiograph as processing the signal "transmitted through two or more electrocardiograph electrodes". A device that displays a difference requires at least two points to take the difference between, which is why the definition sets the floor at two. A twelve-lead recording is a display convention built from several such pairs, not a different device.
That matters for a specifying buyer in a small way and a filing way. A single-channel handheld recorder and a twelve-channel cart are the same device type under the entry, and the number of leads is a specification rather than a classification. A clinic that records the lead configuration as part of the device class is recording a specification in a class field.
The electrode entry sets no number at all, which is consistent with an accessory that is pooled and applied. The count belongs to the procedure, and the procedure belongs to the clinic. A clinic that writes the electrode count into the device record has put a procedural detail where a class belongs, and the same clinic will struggle to answer a question about which device was in use on a given day.
What has to be recorded for an ECG device?
Six records, and the two that most often go missing are the electrode lot and the calibration check.
- The device and its class. The monitor and the electrode recorded as separate items, each with the section or rule that gives its class.
- The electrode lot. Traceability for an adhesive product that contacts skin, kept per box rather than per carton.
- The calibration or self-test. The check the monitor performs and the result, recorded at the interval the manufacturer states.
- The lead configuration. The channels used and the placement, recorded because the trace means nothing without the placement.
- The patient preparation. Skin preparation before application, recorded because it is the step that most often explains a noisy trace.
- The consumable record. The electrodes used and the lot, kept with the trace so a claim can be answered from the file.
Which consumables does an ECG station restock?
An ECG station consumes electrodes, paper and preparation items on one cycle. For clinics and multi-site groups buying at case level, the wholesale ordering page sets out account and case terms, and the B2B wholesale collection lists the lines held for institutional buyers. The exam table paper covers the couch, the nitrile examination gloves cover preparation and cleanup, and a site that also runs its own steriliser can pair the monitoring collection with the biological indicator 5-pack trial.
Sources
- 21 CFR 870.2340, electrocardiograph
- 21 CFR 870.2360, electrocardiograph electrode
- 21 CFR 870.2910, radiofrequency physiological signal transmitter
- 21 CFR 862.1675, blood specimen collection device
- Medical Devices Regulations, SOR/98-282, full text and Schedule 1
- ISO 13485:2016, medical device quality management systems
- ISO 14971:2019, risk management of medical devices
- ISO 15189:2022, medical laboratories
- ISO 15004-1:2020, ophthalmic instruments
- Health Canada, medical devices
- Health Canada, drug and health product portal
- openFDA device classification API
- CCOHS, OSH answers
- CCOHS, needlestick injuries
- World Health Organization, laboratory biosafety manual
- OSHA, bloodborne pathogens
- Public Health Ontario, laboratory services test index
- Public Health Ontario, specimen acceptance criteria
- College of Medical Laboratory Technologists of Ontario
- Royal College of Dental Surgeons of Ontario
A trace is only as good as the electrode lot under it. The printable device and consumable log is a free sheet with a column for the electrode lot and a column for the calibration check, so the two are never written on the same line. The generator sized to a diagnostic room builds the sheet from the number of recordings a room performs and the devices it holds, which keeps a family practice from being handed a hospital form. No account and no sign-up are needed to open either one.
Where the split between a device and its accessory needs to be explained for a filing, the written answer is the one worth having. Ask a compliance specialist and a written answer comes back specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Blood Draw Chairs in Canada vs the US: Which Device Rules
- Blood Pressure Monitor Thresholds in Canada vs the US
- Blood Collection Station Consumables: A Canadian Safety Checklist
CliniEco Medical supplies laboratory, eye care and dental consumables of the kind described in this article. MDEL #35334. This article is written for clinical, diagnostic and procurement professionals and is not safety or regulatory guidance; the acceptance of a device and the records kept by a facility belong to its quality system and to the requirements that apply to it.
Frequently Asked Questions
Is an electrocardiograph a Class II device in the United States?
Yes. Section 870.2340 places the electrocardiograph in Class II, and the control is stated as performance standards.
Are ECG electrodes a separate device from the monitor?
Yes. Section 870.2360 covers the electrocardiograph electrode as its own entry, placed in Class II with special controls and exempt from premarket notification subject to 870.9.
What is the special control for an ECG electrode?
The entry names the special control as the FDA guidance document entitled "Class II Special Controls Guidance Document: Electrocardiograph Electrodes".
How many electrodes does the American definition require?
The definition describes an electrocardiograph as processing the signal transmitted through two or more electrocardiograph electrodes, so two is the floor and the lead configuration is a specification rather than a class.
How is an ECG device classified in Canada?
There is no named entry in Schedule 1. A device that records rather than penetrates is reached through the general rules, and an electrode applied to intact skin is a non-invasive device, while a device intended for use on compromised skin is described by a different rule.
Which records should an ECG station keep?
Keep the monitor and electrode as separate items with their class sources, the electrode lot, the calibration or self-test result, the lead configuration and placement, the skin preparation step, and the lot used for each trace.
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