InControl Medical Pelvic Floor Muscle Stimulators Receive Class 2 Medical License for Sale in Canada
InTone, Apex and Intensity certified as meeting all safety, effectiveness and labeling requirements
BROOKFIELD, Wis.–(BUSINESS WIRE)–InControl Medical LLC, a women’s health company, has received a Class 2 Medical Device License from theHealth Canada Medical Devices Bureau. The license is effective as of November 26, 2013, and allows the sale of InControl products throughout Canada.
“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”
Certification designates that the company’sInTone®,Apex™andIntensity®devices meet comprehensive safety, effectiveness and labeling requirements. An important part of this certification is the company has receivedISO 13485quality certification from theInternational 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, andlook forward to bringing the benefits ofInTone®,Apex™andIntensity®to women throughout Canada.”
The InControlInTone®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 theInTone®device, as it has been shown to significantly improve greater than 93% of users. Similarly,Apex™provides treatment for mild to moderate stress urinaryincontinence through delivery of patented muscle stimulation and active exercise using a customizable probe to strengthen the pelvic floor. TheIntensity®device also provides muscle stimulation for muscle toning in combination with features to enhance sexualresponse.
For more information about InControl Medical LLC,InTone®, orApex, seehttp://www.incontrolmedical.com.
For Intensity, seehttp://pourmoi.com/.
For InControl Medical
Suzy Ginsburg, 713-721-4774