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Thursday, 10/27/2016 11:38:58 AM

Thursday, October 27, 2016 11:38:58 AM

Post# of 329209
FDA OTC Market Clearance - The Company has submitted a 510(k) pre market application to the FDA with three ActiPatch randomized clinical trials. Additionally, the clinical trials evidence is being supplemented with a Registry of a 5,600 consumer assessment on back pain, a 6-Month Observational Study on product durability, a Medication Use Reduction Study and a Sleep Improvement Study.