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# Hinge Health Wireless Pain Device Cleared
- URL: https://www.fdaweb.com/hinge-health-wireless-pain-device-cleared/
- Published: 2024-09-11T12:00:00.000Z
- Updated: 2026-09-14T14:40:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157759

FDA has cleared a Hinge Health 510(k) for its [Enso 3](https://www.hingehealth.com/enso/?ref=fdaweb.com), a wireless device that the company says is clinically proven to reduce musculoskeletal pain. “The new Enso 3 delivers electrical nerve stimulation that achieves non-invasive, non-addictive pain relief within minutes,” it says.

The clearance was based on data from a recent [randomized controlled trial](https://www.dovepress.com/articles.php?article%5Fid=94386&ref=fdaweb.com) involving 325 participants that showed “superior pain reduction compared to a traditional transcutaneous electrical nerve stimulation (TENS) device and exercise therapy alone,” according to Hinge Health. It says that after using the device for four weeks alongside exercise therapy patients were 2.3 times more likely to achieve clinically meaningful pain reduction than those using traditional TENS devices alongside exercise therapy.