> ## Documentation Index
> Fetch the complete documentation index at: https://docs.sonohealth.com/llms.txt
> Use this file to discover all available pages before exploring further.

# Is the SonoHealth Fetal Doppler FDA Cleared?

> Yes. The SonoHealth HeartBeats™ Fetal Doppler is FDA-cleared for home use. Learn what FDA clearance means, what it does not mean, and how it compares to non-cleared devices.

**Yes. The SonoHealth HeartBeats™ Fetal Doppler is FDA-cleared for home use as a fetal heart rate monitor.**

FDA clearance means the device has been reviewed and authorized by the U.S. Food and Drug Administration as a medical device that is substantially equivalent in safety and effectiveness to a legally marketed predicate device.

## At a Glance

| | Detail |
| - | - |
| FDA Status | FDA-cleared ✅ |
| Device Type | Class II medical device |
| Pathway | 510(k) clearance |
| Intended Use | Home fetal heart rate monitoring for reassurance and bonding |
| Not Intended For | Medical diagnosis or replacement of clinical prenatal care |

## What FDA Clearance Means

FDA clearance under the 510(k) pathway means that SonoHealth demonstrated to the FDA that the HeartBeats™ Fetal Doppler is **substantially equivalent** in safety and intended use to a legally marketed predicate device. The FDA reviewed the technical specifications, including:

* Ultrasound output levels (safety)
* Probe frequency (2.5 MHz)
* Intended use (non-diagnostic home monitoring)
* Labeling and user instructions

Cleared devices are legally authorized for sale in the United States and must comply with ongoing FDA quality system regulations.

## What FDA Clearance Does NOT Mean

> [!WARNING]
>
> FDA clearance does not make a fetal doppler a diagnostic device. The HeartBeats™ is cleared for reassurance and bonding — not for clinical diagnosis, not for monitoring high-risk pregnancies, and not as a substitute for professional prenatal care.

FDA-cleared home fetal dopplers are intended to:

* Let expectant parents hear their baby's heartbeat for bonding
* Provide reassurance between prenatal appointments
* Detect fetal heart rate in BPM

They are **not** intended to:

* Replace obstetric ultrasounds
* Monitor fetal distress
* Diagnose pregnancy complications
* Serve as a clinical tool

## How It Compares to Non-Cleared Devices

Many cheap fetal dopplers sold on Amazon and through generic marketplaces are **not FDA-cleared**. These devices:

* Have not been reviewed for safety or accuracy
* May have inconsistent ultrasound output levels
* Are not legally authorized as medical devices in the US
* Often lack proper labeling or instructions

| | SonoHealth HeartBeats™ | Generic Marketplace Doppler |
| - | - | - |
| FDA-Cleared | ✅ Yes | ❌ Often No |
| Device Type | Class II medical device | Unregistered |
| Safety Review | FDA reviewed | None |
| 2.5 MHz Probe | ✅ | Varies |
| Warranty | 1 year | Usually none |

## When to Contact Your Provider

The HeartBeats™ Fetal Doppler is a reassurance tool — not a clinical monitor. Always contact your healthcare provider if:

* You cannot detect a heartbeat and are past 12 weeks
* Baby's movements seem reduced or absent
* You have any concerns about your pregnancy
* You experience pain, bleeding, or unusual symptoms

A fetal doppler should never be used to delay or replace medical evaluation.

> [card] [Shop HeartBeats™ Fetal Doppler](https://sonohealth.com/products/fetal-doppler/)
>
> FDA-Cleared · 2.5 MHz · 1-Year Warranty · \$69


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