FDA Clearance for PainEraser Systems’ products
All of our PainEraser Systems products conform to the FDA product code: IRO, FDA device category: Class I, subcategory: Therapeutic vibrator, FDA regulation number: 890.5975 FDA device exempt from pre-manufacturing notification and device approval requirements.
The FDA allows the sale and use of PainEraser Systems’ products in home and professional health care settings.
The FDA has issued guidance by way of letters to other manufacturers that health claims must be limited to muscle pain and spasm. Our website will provide links to peer-reviewed research articles to help PainEraser Systems products users become familiar with the latest scientific knowledge about “focal vibratory therapy”, a term frequently used in the medical literature.
FDA References:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=890.5975
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.cfm?GMPPart=890#start