BioElectronics Worldwide Class IIa OTC Market Clearances
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.
NHS- 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.