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SIM™ (Smart Incontinence Management) is indicated for use by healthcare professionals to remotely monitor wetness events, and collect, transmit and report wetness events and other medical information from multiple patients within a clinical setting (e.g., hospitals, skilled nursing facilities, residential care facilities), to establish effective management care plans for continence events.

SIM™ consists of disposable incontinence pads with embedded sensors, a wireless transceiver, hardware, and software.

The proposed product, Hughes Bowel and Bladder System Model MeD-18, is an enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected, that may be used by an ambulatory adult to assist in the control of incontinence. Hughes Bowel and Madder System model MeD-18 helps persons with incontinence manage of overcome bladder control problems by providing them with a private alarm system to detect when uncontrolled urination or excretion begins. Hughes Bowel and Bladder System, model MeD-18, assists in controlling incontinence so that the wearer can manage their comditon promptly and with complete discretion at the first sign of bladder or bowel release day or night.

The proposed product, Hughes Bowel and Bladder System Model MeD-18, is an enuresis alarm, a device to detect urine and/or feces and to set off a vibratory alarm when detected, that may be used by an ambulatory adult to assist in the control of incontinence. The device functions with a pager-like motor that vibrates to inform the wearer of urine / feces spillage.

Potty Pal: This device is indicated as a daytime enuresis alarm that may be used by a parent or caregiver to assist toddlers in toilet training. Forevery Dry: This device is indicated as nighttime enuresis alarm to aid in solving a child's nighttime bedwetting problem.

The Forever Dry and Potty Pal consist of: Training parts, which has sewn in mylas conductive strips. The strips are connected to an audible alarm. Powered by a 9V battery

The proposed device, DryTime® for Bladder Control Silent, is a daytime enuresis alarm that may be used by an ambulatory adult to assist the control of incontinence. It is designed and used in a manner consistent with the predicate device (l.e., the emission of bodily fluids is detected when those fluids complete an electrical circuit in a sensor device and thereby set off an electronic alarm).

The proposed device. DryTime® for Bladder Control Silent, is a daytime enuresis alarm that may be used by an ambulatory adult to assist in controlling incontinence. It is designed and used in a manner consistent with the predicate device (i.e., the emission of bodly fluids is detected when those fluids complete an electrical circuit in a sensor device and thereby set off an electronic alarm). DryTime for Bladder Control Silent contains the identical components used in the Health Sense International predicate device, DryTime for Potty Training, except that DryTime® for Bladder Control Silent uses a silent vibrator alarm in place of the audio buzzer alarm of DryTime® for Potty Training. DryTime for Bladder Control Silent is comprised of a disposable fluid sensor strip unit (Sense'R Strip") attached to a silent vibrator alarm unit, which, in turn, clips via a soft vinyl strap to the front of the undergarment about two inches below the outside of the walstband (fabric is pinched to allow the jaws of clip to attach). The sensor strip unit is the Identical Sense 'R Strip® of the approved DryTime® for Potty Training predicate device, and includes two parallel vertical aluminized mylar sensor strips which are spaced a short distance apart from each other and which are electrically connected to the silent vibrator alarm unit. These aluminized mylar sensor strips are encased inside a disposable soft, absorbent paper sheath; the outer portion of the paper sheath is composed of apertured paper and the inner portion is made of a highly absorbent paper which is in contact with the aluminized mylar sensor strips. When the sensor unit is attached to the undergarment, the sensor strip unlt is extended downward inside the undergarment to lay over the groin. The top side of the paper sheath surrounding the two aluminized mylar sensor strips has an adhesive which secures the strip to the undergarment. The adhesive is exposed by peeling a paper backing from the sensor strip unit. When the subject urinates or defecates, the released fluid is absorbed by the inner portion of the sensor strip unit through the holes of the outer apertured paper. The absorbed fluid contacts the aluminized mylar sensor strips encased within the paper sheath, and creates a "bridge" between the two conductive strips so that the electrolytes in the fluid complete an electrical circuit with those strips. Once the circuit is completed by the fluid, the alarm is activated to indicate that the person wearing the device has elther urinated or defecated. At the same time the circuit is completed, a transistor in the alarm unit switches the current to another circuit, thereafter bypassing the aluminized mylar sensor strips. This ensures that the alarm will remain activated once fluld has been detected, regardless of any movements by the subject that might otherwise break the initial circuit created by the fluid bridge between the mylar sensor strips. The activation of the transistor also ensures that current no longer flows through the aluminized mylar sensor strips.