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# BioElectronics 510(k) for Musculoskeletal Pain Patch
- URL: https://www.fdaweb.com/bioelectronics-510-k-for-musculoskeletal-pain-patch/
- Published: 2019-08-21T12:00:00.000Z
- Updated: 2026-09-15T01:45:08.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144824

BioElectronics has filed a 510(k) that seeks expanded clearance for its ActiPatch Musculoskeletal Pain Therapy, a drug free, over-the-counter device seeking an indication for “adjunctive treatment of musculoskeletal complaints pain.” The device is already FDA-cleared for over-the-counter treatment of pain from knee osteoarthritis and plantar fasciitis. The submission includes data from a cervical osteoarthritis (neck pain) study that compared the effectiveness of ActiPatch treatment to that of a standard of care treatment (prescription Cox-2 inhibitor etoricoxib 60mg), according to the company. “Data from the study indicates that both treatments significantly reduced neck pain, but that ActiPatch was superior to NSAID \[etoricoxib\] treatment (statistically significant),” it says.