Written and maintained by CASRAI Editorial Board
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This page describes products and general use; it is not medical advice.
A CPR feedback device is a tool used while CPR is being performed that gives the rescuer real-time audio and/or visual information on the quality of the compressions or ventilations, so the rescuer can adjust. In the United States the FDA regulates it as a Class II device, which separates it from a simple prompting aid and from a mechanical chest compressor. This guide is for clinic staff, facility planners and students who need to tell those three product classes apart and know what the federal rules require a manufacturer to state on the labeling.
What is a CPR feedback device?
Under 21 CFR 870.5210(b)(1), a CPR aid with feedback is a device that provides real-time feedback to the rescuer on the quality of CPR being delivered, using audio and/or visual information, to encourage consistent application of effective manual CPR in line with current accepted guidelines. The regulation lists the kinds of parameters involved: compression rate, compression depth, ventilation and recoil, and instruction for one or multiple rescuers. Such a device may also coach the rescuer through the sequence of steps.
Who uses it: the regulation describes CPR aids (the no-feedback type is stated outright) as intended for persons professionally trained in CPR, and the labeling of a feedback device must state any clinical training needed for safe use.
What it measures and how it is built
The regulation is technology-neutral. A feedback device can contain software, or it can be mechanical or electro-mechanical with no software. What every version has in common is the output: audio cues, visual cues, or both, tied to compression rate, compression depth, ventilation or recoil. Parts that touch the person receiving CPR must be shown to be biocompatible, and any device with electrical components must be shown to be electrically safe and electromagnetically compatible in its intended environment.
Types: feedback aid, no-feedback aid and mechanical compressor
People searching for a “mechanical CPR device” or a “chest compression device” are often looking for a different product class from a feedback device. The FDA separates three of them in two neighbouring regulations.
| Device type | What it does | FDA class | Source |
|---|---|---|---|
| CPR aid without feedback | Performs a simple function such as proper hand placement and/or simple prompting for rate or timing of compressions and breathing; offers no feedback on the quality of the CPR being given | Class I (general controls); exempt from premarket notification, subject to the limits in 21 CFR 870.9 | 21 CFR 870.5210(a) |
| CPR aid with feedback | Gives real-time audio and/or visual feedback on the quality of CPR to the rescuer, who still performs the compressions | Class II (special controls) | 21 CFR 870.5210(b) |
| External cardiac compressor (mechanical CPR device) | A prescription device, electrically, pneumatically or manually powered, that itself compresses the chest to provide blood flow during cardiac arrest; used as an adjunct to manual CPR when effective manual CPR is not possible, for example during patient transport, extended CPR when fatigue may prohibit consistent compressions, or when too few EMS personnel are available | Class II (special controls) | 21 CFR 870.5200 |
Feedback device versus mechanical CPR device
A feedback device guides a person who is doing the compressions. A mechanical CPR device (an external cardiac compressor) does the compressing. The regulation for the compressor requires an “adjunctive use only” indication to be prominently displayed on the device and in its manuals, which is a labeling requirement that the feedback-aid regulation does not contain.
FDA classification and labeling: what the special controls require
The special controls in the regulations double as a list of what a manufacturer must demonstrate, and so of what the labeling and supporting documentation should address.
| Requirement | CPR aid with feedback (870.5210(b)(2)) | External cardiac compressor (870.5200(b)) |
|---|---|---|
| Performance testing | Nonclinical testing under simulated conditions must show the accuracy and reliability of feedback on compression rate, depth and/or respiration over the intended duration and environment of use | Nonclinical testing under simulated physiological conditions must show reliable delivery of specific compression depth and rate over the intended duration |
| Labeling: training | Clinical training, if needed for safe use | Clinical training necessary for safe use |
| Labeling: patient population | Population for which effectiveness was demonstrated, including size and/or age limits (adult, pediatric, infant) | The same population information |
| Labeling: other | None additional listed | Adjunctive-use-only indication; time necessary to deploy the device as shown in testing |
| Electrical safety | Required for devices with electrical components, including electromagnetic compatibility | Same |
| Software | Verification, validation and hazard analysis for devices containing software | Same |
| Biocompatibility | Required for parts in human contact | Same |
| Human factors | Testing must validate that design and labeling are sufficient for effective use by the intended user | Same, including evaluation of the time to deploy |
One further rule matters for mechanical designs: under 870.5210(b)(3), a feedback device is exempt from premarket notification if it contains no software (for example, it is mechanical or electro-mechanical) and complies with the special controls, subject to the limits in 21 CFR 870.9. Devices that contain software do not get that exemption under this paragraph.
How to choose: criteria the regulations put on the label
The federal rules do not rank products, and this page does not either. They do identify what the labeling of a feedback device must tell a buyer, so these are fair questions to ask when reading a product’s instructions for use:
- Which patient populations (adult, pediatric, infant) and size or age limits was it shown to be effective for?
- What clinical training does the labeling say is needed for safe use?
- Which parameters does it give feedback on (rate, depth, ventilation, recoil), and how is the feedback delivered, by audio, visual cues or both?
- Does the labeling describe nonclinical testing of feedback accuracy over the intended duration and environment of use?
Safe use and handling basics
Use a feedback device only as its instructions for use describe, and only within the population limits on its labeling. The regulation describes a feedback device as encouraging effective manual CPR, so it supports a rescuer who is performing CPR; it is not a substitute for the clinical training the labeling calls for. Follow the manufacturer’s directions for cleaning, battery or power checks and storage, which vary by product and are not set out in the regulation.
Common mistakes
- Treating a feedback device as a mechanical CPR device. The first guides a rescuer; the second is a prescription external compressor labeled for adjunctive use only.
- Treating a simple prompting aid as a feedback device. A device that only helps with hand placement or prompts timing is a CPR aid without feedback under 870.5210(a), because it gives no feedback on the quality of the CPR.
- Using a device outside its labeled population. Effectiveness is established for the populations named on the labeling, including size and age limits.
Frequently asked questions
What is a CPR feedback device?
A device that gives the rescuer real-time audio and/or visual feedback on the quality of CPR, such as compression rate, depth, ventilation or recoil. The FDA classifies it as Class II under 21 CFR 870.5210(b).
Is a mechanical CPR device the same thing?
No. A mechanical CPR device is an external cardiac compressor under 21 CFR 870.5200. It compresses the chest itself, is a prescription device, and is indicated as an adjunct to manual CPR when effective manual CPR is not possible.
Is a chest compression device a feedback device?
Not necessarily. “Chest compression device” can mean a mechanical compressor (870.5200) or a hand-placement or prompting aid (870.5210(a)). A feedback device (870.5210(b)) reports on the quality of compressions a person is giving.
Does a feedback device need FDA premarket notification?
One without software, such as a mechanical or electro-mechanical design, that meets the special controls is exempt from premarket notification, subject to 21 CFR 870.9. The regulation does not extend that exemption to devices containing software.
Related reading on CASRAI: what a defibrillator is, AED trainers, AED facility selection and compliance and what a crash cart is. Supplies for emergency response are listed under emergency, trauma and crisis response.
Sources
- 21 CFR 870.5210, Cardiopulmonary resuscitation (CPR) aid: https://www.ecfr.gov/current/title-21/section-870.5210 (checked 2026-10-30; mirrored at https://www.law.cornell.edu/cfr/text/21/870.5210).
- 21 CFR 870.5200, External cardiac compressor: https://www.ecfr.gov/current/title-21/section-870.5200 (checked 2026-10-30; mirrored at https://www.law.cornell.edu/cfr/text/21/870.5200).
