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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Electrostim Medical Services Inc. 4/20/11

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 10903 New Hampshire Avenue
Silver Spring, MD 20993

 

 APR 20, 2011
 
 
Warning Letter
                                               
 
Mario Garcia
President and CEO
Electrostim Medical Services Inc, dba EMSI
3504 Cragmont Dr, Suite 100
Tampa, FL 33619
 
RE: FLEX IT, FLEX MT, FLEX TENS
 
Dear Mr. Garcia:
 
Refer to CMS Case number 104945 when replying to this letter.
 
During an inspection of your firm located in Tampa, Florida, from February 22, 2010, through February 24, 2010, an investigator from the United States Food and Drug Administration (FDA) learned that your firm is marketing the FLEX IT, the FLEX MT, and the FLEX TENS in the United States (U.S.) without marketing clearance or approval, in violation of the Federal Food, Drug, and Cosmetic Act (the Act).
 
The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed http://www.wecontrolpain.com for FLEX IT, FLEX MT, FLEX TENS. The products are devices within the meaning of Section 201(h) of the Act because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or are intended to affect the structure or function of the body of man or other animalsYour website promotes the above devices for uses for which the devices are not cleared. These claims cause the FLEX IT, FLEX MT, and FLEX TENS to be adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. 351(f)(1)(B), because you do not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. 360j(g). 
 
The above-mentioned devices are also misbranded under section 502(o) the Act, 21 U.S.C. 352(o), because you did not notify the agency of your intent to introduce the devices into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. 360(k).
 
Lack of 510(k) for FLEX IT
FDA cleared the FLEX IT under K071869 for the symptomatic relief of the chronic intractable pain, adjunctive treatment for the management of post-traumatic or post-surgical pain
 
However, your website, http://wecontrolpain.com/flex_it_protocol.aspx, promotes the device for the treatment of (b)(4) These claims constitute new indications for use that require a new 510(k) submission under 21 CFR 807.81(a)(3)(ii) for a major change or modification in the intended use of the device. All of the aforementioned new labeling claims likely would require valid clinical performance data in a new 510(k) submission. 
 
Lack of 510(k) for FLEX MT
FDA cleared the FLEX IT under K071869 for the following intended uses: 
 
TENS-Transcutaneous Nerve Stimulation
  •         Symptomatic relief of chronic intractable pain
  •         Post Traumatic and postsurgical pain relief
EMS-Electrical Muscle Stimulation
  •          Relaxation of muscle spasm
  •          Increasing local blood circulation
  •          Muscle re-education
  •          Prevention or retardation of disuse atrophy
  •          Prevention of venous thrombosis of the calf muscles immediately after surgery
  •          Maintaining or increase range of motion
However, your website, http://wecontrolpain.com/flex_mt_protocol.aspx, promotes the above device for the treatment of (b)(4) These claims constitute new indications for use that would require a new 510(k) submission under 21 CFR 807.81(a)(3)(ii) for a major change or modification in the intended use of the device. All of the aforementioned new labeling claims for this device likely would require valid clinical performance data in a new 510(k) submission. 
 
Lack of 510(k) for FLEX TENS
FDA cleared the FLEX IT under K071869 for the
Symptomatic relief of chronic intractable pain, post traumatic and post surgical pain relief
 
However,your website, http://wecontrolpain.com/flex_tens_protocol.aspx, promotes the above device for the treatment of (b)(4) These claims constitute new indications for use that would require a new 510(k) submission under 21 CFR 807.81(a)(3)(ii) for a major change or modification in the intended use of the device, whether the device is used by itself or in conjunction with the FLEX-GAR SOCK, the FLEX-GAR CERVICAL, or the FLEX-GAR SHOULDER. All of the aforementioned new labeling claims for this device likely would require valid clinical performance data in a new 510(k) submission. 
 
The Office of Compliance requests that EMSI immediately cease the dissemination of promotional materials for FLEX IT, FLEX MT, and FLEX TENS the same as or similar to those described above. You should take prompt action to correct these violations. Failure to promptly correct these violations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to seizure, injunction, and civil money penalties.
 
Please submit a written response to this letter within 15 working days from the date you receive this letter, describing your intent to comply with this request, listing all promotional materials for FLEX IT, FLEX MT, FLEX TENS the same as or similar to those described above, and explaining your plan for discontinuing use of such materials. Please direct your response to Charles Cathlin at the Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD 20993, facsimile at 301-847-8128. We remind you that only written communications are considered official.
 
The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for FLEX IT, FLEX MT, and FLEX TENS comply with each applicable requirement of the Act and FDA implementing regulations. 
 
Sincerely,
/S/
Steven D. Silverman
Director
Office of Compliance
Center for Devices and
   Radiological Health