FDA Clearance 

PainEraser by NMT

The PainEraser: FDA product code: IRO, FDA device category: Class I, subcategory: Therapeutic vibrator, FDA regulation number: 890.5975 FDA device exempt from premanufacturing notification and device approval requirements.

The FDA allows the sale and use in home and professional health care settings of the PainEraser by NMT

Class I/II Exemptions:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051549.htm

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