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# FDA Clears TrainHealth’s Neuromuscular Stimulator
- URL: https://www.fdaweb.com/fda-clears-trainhealths-neuromuscular-stimulator/
- Published: 2025-03-31T12:00:00.000Z
- Updated: 2026-09-14T14:56:37.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158924

FDA has cleared a TrainHealth 510(k) for its TrainFES \[functional neuromuscular stimulator\] Advanced device and its use in treating people with sequelae of stroke and spinal cord injury. The device uses smart electrical stimulation that moves the paralyzed limbs of patient to increase both adherence and functional results, the company says.

The clearance is based, it says, on results from a [study conducted by the University of Illinois Chicago](https://www.globenewswire.com/Tracker?data=iayYJKhxruAFhflLzTQYvHCmxkbmmdlZCvVvsEISrEU60lEYeegAHHF1qFjFAQHOJb4ynIf4z%5F4FleOHRMejjL8i%5F-XASM9IInkV409pfKJgxCS%5FvYEtCwXuhM1YKfyYOwT2yTpxMnocflsCCquALlplsu63sTg9ifY34Uvgz40Lv6qmMiZgzz85ojjdyFfPtJ50QgjzevywQ3mHXfIMtCbG9t%5FzoQRLikcMel9Z-nqyuICFRfqElZLiB8eq0%5FyyKsIICpVTZvW06f9AjFpOj5Ktv47x3f9QW1ckkfEBD-1YwUAYedCsxczcp1652kiG767VjZ5p7W0LisYJoisJV9FyTanPIgucDgiKqVdjZEI=&ref=fdaweb.com), which showed “significant improvements in gait and balance were observed while using the device in the home rehabilitation of patients for six weeks with an 84% adherence and improvements of up to 40% in motivation, acceptance and usability of the system.”