Is This Treatment FDA Approved?
The Aspen After Surgery Treatment ( Aspen Rehab Technique) is a Patented Therapeutic Treatment Program that collectively utilizes clinical protocols and technologies that are licensed to do so under our medical practice act as well as technologies FDA approved for their specific indications. The Aspen treatment makes no claim on technology or devices alone to treat or diagnose.
The therapeutic treatment protocols have been designed and are rendered by licensed medical professionals under medical practice guidelines and should not be delivered by anyone without the license or training to do so.
The technologies/ devices utilized as part of the Aspen treatment protocols make no claim of specificity to treat or diagnose outside of their approved FDA / 510K.
These technologies/devices combined with the therapeutic technique are allowable and approved under respective practice acts and medical licensure to treat after a proper evaluation and set plan of care by an approved licensed medical professional.
CURRENT FDA APPROVED INDICATIONS for the Aspen Harmonizer are: Relief of Pain/ Joint Contractures, Aspen Illuminizer: Local Blood flow, Circulation, Relaxation of muscles, Aspen Stimulizer : Management of traumatic or post-surgical pain.
FUTURE FDA INDICATIONS:
The Aspen Harmonizer is currently approved and in progress for a study that is seeking specificity for particular device claims. The study is approved to assess the success of the Aspen Harmonizer for treatment of breast implant capsular contracture as well as show safety to the implant with treatment. Details of the current status of this study are here: https://clinicaltrials.gov/ct2/show/NCT02840084