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TMCNet:  InControl Medical Pelvic Floor Muscle Stimulators Receive Class 2 Medical License for Sale in Canada

[December 02, 2013]

InControl Medical Pelvic Floor Muscle Stimulators Receive Class 2 Medical License for Sale in Canada

BROOKFIELD, Wis. --(Business Wire)--

InControl Medical LLC, a women's health company, has received a Class 2 Medical Device License from the Health Canada Medical Devices Bureau. The license is effective as of November 26, 2013, and allows the sale of InControl products throughout Canada.

Certification designates that the company's InTone®, Apex and Intensity® devices meet comprehensive safety, effectiveness and labeling requirements. An important part of this certification is the company has received ISO 13485 quality certification from the Internatioal Organization for Standardization (ISO).


"This certification from Health Canada is the latest step in InControl Medical's effort to expand distribution of our products in countries outside of the United States," said Chief Executive Officer and founder Herschel "Buzz" Peddicord. "We are gratified by Health Canada's thorough and efficient review process, and look forward to bringing the benefits of InTone®, Apex and Intensity® to women throughout Canada."

The InControl InTone® is a non-invasive treatment to stop bladder leakage associated with stress, urge and mixed urinary incontinence. InTone® utilizes a customizable probe, patented muscle stimulation, active resistance and biofeedback to dramatically increase muscle strength in the pelvic floor. Improvement is marked when using the InTone® device, as it has been shown to significantly improve greater than 93% of users. Similarly, Apex provides treatment for mild to moderate stress urinary incontinence through delivery of patented muscle stimulation and active exercise using a customizable probe to strengthen the pelvic floor. The Intensity® device also provides muscle stimulation for muscle toning in combination with features to enhance sexual response.

For more information about InControl Medical LLC, InTone®, or Apex, see http://www.incontrolmedical.com.

For Intensity, see http://pourmoi.com/.


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