Worldwide Market Clearances

Worldwide Market Clearances

In the United States, BioElectronics products are cleared by the FDA for the treatment of edema following blepharoplasty.

In the international markets, the product is consistently classified as a low risk OTC product.

In Canada, ActiPatch is a Class II device and is sold Over-The-Counter; Health Canada has approved it for relief of pain in musculoskeletal complaints.

The device also has EU and Australian OTC approval as a Class IIa. The indication of use in the European Common Market is for edema reduction, swelling, pain and inflammation.

Additionally, in Korea, ActiPatch is cleared for the reduction of muscle pain in the back, knee, wrist, elbow and heel.