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Electrome · Evidence

Regulatory Clearances

FDA 510(k) clearance records for the underlying ActiPatch® and RecoveryRx devices.

regulatory

RecoveryRx (wearable pulsed shortwave therapy / PSWT device for post-surgical applications) — FDA 510(k) K190251

Adjunctive treatment of postoperative pain

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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; RecoveryRx® is FDA-cleared (K190251) for adjunctive treatment of postoperative pain. Study outcomes such as edema reduction are evidence findings, not additional cleared indications. Both devices are developed and manufactured by BioElectronics Corporation and marketed by Electrome under an exclusive license.