CORRECTING and REPLACING InControl Medical: Maker of InTone, Apex and Intensity, Receives ISO 13485 and CE Mark Medical Device Approvals

Quality certifications facilitate greater access to global markets for patented, U.S.-manufactured devices

CORRECTION…by InControl Medical

BROOKFIELD, Wisc.–(BUSINESS WIRE)–Headline of release dated November 6, 2013 should read: InControl Medical: Maker of InTone, Apex and Intensity, Receives ISO 13485 and CE Mark Medical Device Approvals (sted Receives ISO 13495 and CE Mark Medical Device Approvals).

“These designations, along with our FDA listing, are important tools that enhance the global reach and acceptance of our products for medical professionals and consumers.”

The corrected release reads:

INCONTROL MEDICAL: MAKER OF INTONE, APEX AND INTENSITY, RECEIVES ISO 13485 AND CE MARK MEDICAL DEVICE APPROVALS

Quality certifications facilitate greater access to global markets for patented, U.S.-manufactured devices

InControl Medical LLC, a women’s health company with a focus on relief of urinary incontinence announces that it has received two important international quality designations:ISO 13485certification from theInternational Organization for Standardization(ISO), and theCE mark of the European Commission(EC) Both signify that the company meets comprehensive quality management requirements in the design and manufacture of medical devices.

InTone™is listed by the U.S. Food & Drug Administration (FDA) as a Class II Medical Device for the treatment of female urinary incontinence.Apex™is the first automatic pelvic floor (Kegel) exerciser for the over 20 million women in the U.S. suffering from unexpected bladder leakage due to coughing, sneezing, laughing or exercise often referred to “stress” incontinence andIntensity™is an intimate health and stimulation device designed to help women exercise the pelvic floor muscles (PFM) for improved sexual health and responsiveness, while calming and relaxing those muscles to reduce pain.

“The global combination of ISO and CE Mark quality conformance means thatInControl Medicalis well positioned to expand our growth internationally, in both established and emerging markets where consumers want and need the assurance of the highest medical device and performance standards,” said ChiefExecutive Officer and founder Herschel “Buzz” Peddicord. “These designations, along with our FDA listing, are important tools that enhance the global reach and acceptance of our products for medical professionals and consumers.”

InToneTMsolves bladder leakage by utilizing several patented muscle stimulation algorithms, active resistance and biofeedback to dramatically increase muscle strength in the pelvic floor, providing effective treatment for stress, urge and mixed female urinary incontinence. Until now the only solution to bladder leakage was by using diapers or pads, taking meds or undergoing surgery. In addition to being an uncomfortable, personally sensitive condition,

incontinence can be related to other health concerns, from pelvic pain to sexual dysfunction. Similarly,ApexandIntensitycombine muscle stimulation and active exercise, acting as a “trip to the gym” for the pelvic floor.
ISO 13485:2003 specifies management system requirements by which a medical device manufacturer demonstrates its ability to provide products and related services that consistently meet applicable regulatory and customer quality and performance requirements. The ISO is the world’s largest developer of voluntary best practices for products and services. CE marking is an EC legal requirement that applies to medical devices intended for sale in Europe. A medical device’s CE Mark assures that it meets the standards of the EC’s Medical Device Directive.“

Very few companies our size achieve this level of quality standard performance,” Peddicord added. “We’ve applied for Canadian and Australian approval, and having the ISO 13485 designation makes entering those countries possible. It is a proud achievement for our patented products, which are manufactured in the United States with locally sourced materials.”

For more information aboutInControl MedicalorInTone, seehttp://www.incontrolmedical.com. For information on Apex and Intensity seehttp://pourmoi.com/.

Contacts

for InControl Medical LLC

Suzy Ginsburg, 713-721-4774

suzy@gcomworks.com