FDA WARNING_LETTER - Non-Invasive Monitoring Systems, Inc. - March 25, 2010

On March 18, 2011, the FDA issued a Warning Letter to Non-Invasive Monitoring Systems, Inc. (NiMS) following an inspection from March 24-25, 2010, in Miami, Florida. The letter stated that NiMS was promoting its Exer-Rest device in the U.S. without marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

The Exer-Rest, classified as a Class I exempt therapeutic vibrator for muscle relaxation and minor pain relief (21 CFR 890.5975), was being promoted on NiMS's website (www.nims-inc.com) for unapproved uses. Examples included "cardioprotective preconditioning," brain damage reduction in ischemic strokes, use during CPR, and for conditions like asthma and fibromyalgia. These uses differ from its legally marketed intended use, requiring premarket notification per 21 CFR 890.9.

Consequently, the device was deemed adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. 351(f)(1)(B)) due to the lack of an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE). It was also misbranded under section 502(o) (21 U.S.C.