FDA WARNING_LETTER - Electrostim Medical Services Inc. - February 24, 2010

This FDA Warning Letter, dated April 20, 2011, addresses Electrostim Medical Services Inc. (EMSI) regarding their FLEX IT, FLEX MT, and FLEX TENS devices. An inspection from February 22-24, 2010, revealed that EMSI was marketing these devices in the U.S. without proper marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

The FDA's Office of Compliance reviewed EMSI's website, wecontrolpain.com, and found that the devices were promoted for uncleared uses. Specifically, the FLEX IT, FLEX MT, and FLEX TENS were promoted for treating conditions beyond their cleared indications (K071869). These new claims constitute new intended uses requiring new 510(k) submissions under 21 CFR 807.81(a)(3)(ii), likely necessitating valid clinical performance data.

Consequently, the devices are deemed adulterated under section 501(f)(1)(B) of the Act due to the lack of an approved premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) for failure to notify the agency of intent to introduce the devices into commercial distribution via a 510(k).

EMSI is required to immediately cease disseminating promotional materials with these uncleared claims