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Electrome · Evidence

Regulatory Clearances

FDA 510(k) clearance record for the underlying ActiPatch® device.

regulatory

ActiPatch® (wearable pulsed shortwave therapy / PSWT device), FDA 510(k) K192234

Adjunctive treatment of musculoskeletal pain

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Educational summary only. Not medical advice. Individual results vary. Consult a qualified healthcare provider before making treatment decisions. ActiPatch® is FDA cleared (K192234) for musculoskeletal pain. Study outcomes such as edema reduction are evidence findings, not additional cleared indications. ActiPatch® is developed and manufactured by BioElectronics Corporation and marketed by Electrome under an exclusive license.
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