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# FDA Rejects BioElectronics Expanded Use for ActiPatch
- URL: https://www.fdaweb.com/fda-rejects-bioelectronics-expanded-use-for-actipatch/
- Published: 2018-11-27T12:00:00.000Z
- Updated: 2026-09-15T00:46:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142901

FDA has declined a BioElectronics 510(k) submission for its ActiPatch, seeking expanded over-the-counter indications for treating musculoskeletal pain. “In the back pain study that was submitted to the FDA as clinical evidence, the ActiPatch was found to have a significant treatment effect in women, but only a mild treatment effect in men,” the company says. “Gender-level analysis of the prior ActiPatch clinical data revealed that there indeed were differences in treatment effects between men and women, with women reporting more pain relief than men. The company intends to leverage these findings and resubmit the 510(k) application for a more specific indication: relief of musculoskeletal pain for women.”