--- title: Are the cuffs FDA-approved? description: General overview of FDA status and classification for BFR cuffs. --- [Skip to content](https://support.saga.fitness/are-cuffs-fda-approved#main-content) [![SAGA White Logo small](https://support.saga.fitness/hs-fs/hubfs/SAGA%20White%20Logo%20small.png?width=400&height=80&name=SAGA%20White%20Logo%20small.png)](https://support.saga.fitness/?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/?hsLang=en) 2. [About BFR Training](https://support.saga.fitness/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/getting-started?hsLang=en) - [Using BFR Cuffs](https://support.saga.fitness/using-bfr-cuffs?hsLang=en) - [Orders & Shipping](https://support.saga.fitness/orders-shipping?hsLang=en) - [About BFR Training](https://support.saga.fitness/about-bfr-training?hsLang=en) - [Troubleshooting](https://support.saga.fitness/troubleshooting?hsLang=en) - [Partner with SAGA](https://support.saga.fitness/partner-with-saga?hsLang=en) [![SAGA Logo Black Small](https://app-na2.hubspot.com/api/filemanager/api/v2/files/371516251834/signed-url-redirect?portalId=242388504 "SAGA Logo Black Small")](https://saga.fitness/) [CONTACT US](https://40b860.share-na2.hsforms.com/2FCbboByNQkirYweuf1hibg) © SAGA Fitness [Privacy Policy](https://saga.fitness/policies/privacy-policy)