Search Results

TENS: The device is intended for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from exercise and/or normal household and work activities. NMS: The device is intended to stimulate healthy muscles in order to improve and facilitate muscle performance.

The Applicant device, XiniWave II Model ECS322P, is a precision Class II device housed in a sturdy lightweight cabinet. The keypad controls and the circuit for the Applicant device are identical to the Predicate. For a maturing user constituency, the cabinet of the Applicant device is larger than the Predicate with a bigger white paper Liquid Crystal Display (LCD), yet the weight of the device is virtually equivalent. The Applicant device is powered by 3 x 1.5V AAA alkaline batteries. The Applicant device offers the user a choice of eight (8) pre-set Transcutaneous Electro Neuro Stimulation (TENS) programs for the temporary relief of pain (80 mA Max.) and one pre-set Neuro-Muscular Electrical Stimulation (NMES) program for muscle conditioning (90 mA Max.). In the NMES mode of operation the user is able to select work/rest stimulation with pulse rates between 2-100Hz and pulse widths between 50-450uS rate may be selected. The mode of action for the Applicant device in TENS or NMES mode is identical to the mode of action to the Predicate. The Applicant device is supplied with skin electrodes (electrode surface minimum of 25cm -), to stimulate the patient. The skin electrodes (extant for the industry) are the same ones as supplied with the Predicate and delineated in the User's Manual. The Applicant device control unit connects directly to the skin electrode by cable and plug (extant for the industry). Sold as a kit, the XiniWave II Model ECS322P kit consists of: One (1) Battery Powered Stimulator (Control Unit) One (1) set of Four (4) skin electrodes Three (3x1.5V) AAA Batteries One (1) User's Manual One (1) case

The device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

The Applicant device, YARLAP II, Model ECS323P, is a portable precision Class II device housed in a sturdy lightweight shock-and water-resistant cabinet with stylus. The device is battery-powered with a full color touch screen Liquid Crystal Display (LCD) and offers the user a choice of six pre-set Neuro-Muscular Electrical Stimulation (NMES) programs with four pre-set biofeedback response-based sound-enriched games. The NMES programs in the Applicant device are Work/Rest modes of operation and identical to the programs in the Predicate. The four biofeedback programs in the Applicant device are to facilitate user graduation from "muscle stimulation" to patient-initiated muscle contractions (i.e., "true exercise"). Neither the Applicant device nor the Predicate have a TENS program. Bluetooth in the Applicant device facilitates gaming and therein patientinitiated "exercise" by permitting use of a larger external Bluetooth compatible display (e.g., computer screen or television). The Bluetooth signal is out-going only. Any external Bluetooth-capable display is optional and is not supplied with the unit. The Applicant device is supplied with a vaginally inserted electrode used with the device to stimulate the muscle of the female pelvic floor (the electrode, essential technology and intended use are identical to the Predicate: K141643). The Applicant device is supplied with a biofeedback reference lead wire with a skin electrode(s). The Applicant device control unit connects directly to the vaginal electrode and reference wire by cable and plug (design extant for the industry).

The device is intended to provide electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in women and to maintain urinary continence in women.

The Applicant device, YARLAP, is a precision Class II device housed in a sturdy lightweight cabinet. The device is battery powered with a backlit Liquid Crystal Display (LCD) and offers the user a choice of six (6) pre-set Neuromuscular Electrical Stimulation (NMES) programs. The NMES programs are Work/Rest modes of operation. The Applicant device has no TENS programs. The Applicant device is supplied with a vaginally inserted electrode specifically designed in 2003 for the hardware, circuit and software used in device to stimulate the female pubococcvgeus (PC) muscle. The Applicant device control unit connects directly to the design-specific electrode by cable and plug (extant for the industry). Sold as a kit, the YARLAP kit consists of: One (1) Battery Powered Muscle Stimulator (Control Unit), One (1) vaginally inserted electrode specifically designed for the hardware. circuit and software used in the Control Unit to stimulate the female pubococcvgeus (PC) muscle, One (1) user's manual, One (1) case.

A. TENS: The device is intended to be used for the temporary relief of pain associated with sore and aching muscles in the lower back, upper extremities (arms) and lower extremities (legs) due to strain from and/ or norrmal non-commercial household work activities. B. NMS: The device is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

The "XINIXWAVE" is a portable combined TENS and NMS dual channel device for OTC use. Housed in sturly but lightweight cabinet, the device is battery powered. The same circuitry is used to for both TENS and NMS.