---
title: Are the cuffs FDA-approved?
description: General overview of FDA status and classification for BFR cuffs.
---
[Skip to content](https://support.saga.fitness/knowledge-base/are-cuffs-fda-approved#main-content)
[.png?width=300&height=50&name=SAGA_logo_White_RGB%20(1).png)](https://242388504.hs-sites-na2.com/knowledge-base?hsLang=en)
Open main navigation
Close main navigation
This is a search field with an auto-suggest feature attached.
- There are no suggestions because the search field is empty.
1. [SAGA Knowledge Base](https://support.saga.fitness/knowledge-base?hsLang=en)
2. [About BFR Training](https://support.saga.fitness/knowledge-base/about-bfr-training?hsLang=en)
# Are the cuffs FDA-approved?
The BFR cuffs are not yet FDA-registered, although registration as a medical device is currently in progress.
It's worth noting that the FDA does not typically approve BFR devices for exercise use, so no devices in this category are 'officially' FDA-approved. Some such products are listed in the FDA database, but this is due to a basic self-registration by the manufacturer, not a formal review.
BFR devices are typically classified as low-risk (Class I) devices. Many products in this category, including pneumatic tourniquets, do not require pre-market approval.
- [Getting Started](https://support.saga.fitness/knowledge-base/getting-started?hsLang=en)
- [Using BFR Cuffs](https://support.saga.fitness/knowledge-base/using-bfr-cuffs?hsLang=en)
- [Orders & Shipping](https://support.saga.fitness/knowledge-base/orders-shipping?hsLang=en)
- [About BFR Training](https://support.saga.fitness/knowledge-base/about-bfr-training?hsLang=en)
- [Troubleshooting](https://support.saga.fitness/knowledge-base/troubleshooting?hsLang=en)
- [Partner with SAGA](https://support.saga.fitness/knowledge-base/partner-with-saga?hsLang=en)
[](https://saga.fitness/)
[CONTACT US](https://40b860.share-na2.hsforms.com/2FCbboByNQkirYweuf1hibg)
© SAGA Fitness
[Privacy Policy](https://saga.fitness/policies/privacy-policy)