Market Clearances

BioElectronics Worldwide  Class IIa OTC Market Clearances

BioElectronics Regulatory Logos

US FDA – The treatment of edema following blepharoplasty.

  • ActiPatch® OTC indication-of-use: Adjunctive treatment of musculoskeletal pain related to: (1) Plantar Fasciitis of the heel; and (2) Osteoarthritis of the Knee
    For the official letter, Click Here

US FDA (Pending) –

  • RecoveryRx® Indication-of-use: Postoperative pain and edema.
  • ActiPatch® OTC indication-of-use: Relief of musculoskeletal pain.
  • Allay® OTC indication-of-use: Relief of menstrual pain and discomfort.

Addition to the Drug Tariff IX April 2018. For the official letter, Click Here

European Union (CE) For the reduction of pain and Inflammation (OTC).

Health Canada Relief of pain associated with musculoskeletal complaints, relief of menstrual pain, and postoperative OTC.

Australia (TGA) For the reduction of pain and inflammation.

Korea Reduction of muscle pain.

Many others around the world.