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The NM-01/CPT neurometer is a noninvasive electrodiagnostic device intended for verifying nerve integrity in conscious adult patients, with intact skin surface. The population of subject for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation. The NM-01/CPT neurometer may be conducted as a part of a routine neurological examination. The measured data can be utilized in evaluating patients suspected of having neuropathies. The measured data must be used in the context of other patient information and must be reviewed and interpreted by a physician. The device is intended for use on adults in medical clinics, healthcare practices and out-patient departments of hospitals.

The NM-01/CPT neurometer is a noninvasive device intentity in conscious adult patients, with intact skin surface. The population of subject for whom this device may be used for diagnostic purposes would include any individual capable of communicating their perception of cutaneous sensation. The NM-01/CPT neurometer may be conducted as a part of a routine neurological examination. The measured data can be utilized in evaluating patients suspected of having neuropathies. The measured data must be used in the context of other patient information and interpreted by a physician. The device is intended for use on adults in medical clinics, healthcare practices and out-patient departments of hospitals. The NEUROMETER NM-01/CPT is a unique neurodiagnostic device that painlessly evaluates the functioning of small unmyelinated (C, small myelinated (A) and large myelinated (A) sensory nerve fibers at any cutaneous site by determining neuro selective sensory nerve conduction threshold. The electronic unit emits non-aversive transcutaneous electrical stimuli through a pair of special noninvasive electrodes in three fixed frequency ranges (thick myelincoated fiber 250Hz, thin myelin-coated fiber 2000Hz) with a manually adjustable current value. The emitted stimulus pulses canbe changed between 0.01 and 9.99 mA and their values qiven by the software are in CPT (Current Precipitation Threshold) values accepted in clinical practice (1CPT = 0.01mA). The test method is sensitive to both hyperesthetic abnormalities, and has more than 800 peer reviewed research publications documenting its diagnostic capabilities. The device can measure sensory nerve function at any cutaneous site including mucosal surfaces such as the bladder and the measures are not affected by skin temperature, edema or electromag-netic interference unlike traditional electro-diagnostic and biopsy procedures. The conducted tests are painless, noninvasive and non-aversive procedure is easy to perform and safe and harmless however it is only for profession clinical use. The evaluation of the tests result could only be approved by a medical doctor but the tests could be conducted by a trained assistant.

The PBM Hair Therapy Cap is indicated to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I to II, males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss, females and males with frontal patterns of hair-loss both with Fitzpatrick Skin Types I to IV.

The PBM Hair Therapy Cap is a hair therapy device that uses red light to help stimulate hair growth in both male and females. The device comes with a Cap that has LED diodes inbuilt and an attachable controller battery pack that comes with an automatic timer that limits the user to 15-minute sessions. The device uses only 660nm LED wavelength diodes on 7 strips, each strip has 12 diodes. These diodes strips are sewn into a cap and has a Type C USB connector that the controller battery pack can connect to. The PBM Hair Therapy Cap is comprised of a fabric cap with inbuilt LED diodes that emit red light on the wavelength of 660nm. The diodes are on strips and the cap style hat has 7 strips with 12 diodes on each strip with a total of 84 LED diodes. A battery powered controller that attaches via a C-type USB connector to the fabric hat is also provided. The controller has a built in 3.7V lithium-ion battery, has an on/off button and in programmed to automatically turn of after 15min of use. The controller also has a 2 small indicator LED's for indicating, power on/in use, needs charging and also blinks while in charging mode. The controller charges via inbuilt C-Type USB port and charges at 500 mA.

The 3.5mm, 4.0mm and 4.5mm Bone Bolt System is indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of small bone fragments, long bones, and long bone fragments of clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, calcaneus, femur, and fibula, and the bones of the hand and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by Bone Bolt fixation. The 5.0mm, 6.0mm and 7.0mm Bone Bolt System is indicated for fixation of fractures, fusions, osteotomies, non-unions, and malunions of long bones and long bone fragments of humerus, radius, ulna, tibia, femur and fibula, pelvis, sacrum, and the bones of the foot in adults and in both children (2-12 years) and adolescents (12-21 years) in which growth plates have fused or in which growth plates will not be crossed by Bone Bolt fixation.

The Bone Bolt System consists of various sizes and lengths of bolts and nut-sleeves, which are implanted from opposing bone surfaces to provide stabilization of bones and bone fragments for the fixation of fractures, arthrodeses, and osteotomies. The bolts and nut-sleeves are cannulated for use with guidewires for precise placement in bone. The Bone Bolt System includes optional washers of various sizes.

The Surgical Gown is intended to be worn by operating room personnel during surgical procedure to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

This product is a new type of SMS breathable non-woven fabric. It consists of collar, gown body and sleeves. The main components of proposed device are: (1)One-piece non-woven fabric Surgical Gown: (2)One-piece helps for better protection and good visuals; (3)Lacing: It is used to tie the belt and fix the shape of the Surgical Gown.

The Vinyl Examination Gloves(Yellow) is a disposable device intended for medical purposes that is worn on the examiner's hands to prevent contamination between patient and examiner.

The subject device is powder free vinyl patient examination gloves. The subject device is yellow. The design of subject device is addressing the standards as ASTM D6124, ASTM D5151, and ASTM D5250. The subject device is nonsterile.

Archworx is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). Archworx is intended to position teeth by way of continuous gentle force.

Devices are intraoral thermoformed plastic aligner trays for tooth malocclusion correction.

TENS function of the device is indicated for the following use: Symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post-traumatic acute pain NMES function of the device is indicated for the following use: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion

The OGYILI TENS/NMES Stimulator E01 is a 2 channel TENS/NMES stimulator device that is used to help reduce pain, with each channel being isolated from the other. The OGYILI TENS/NMES Stimulator is a programmable device that come equipped with 14 preset programs along with 14 user programs. The user programs are adjustable and can be changed to best help the patient at the doctor's recommendation and prescription settings. The program modes are preset programs that a clinician can conveniently choose from should they desire. This device has a special masking program to make the unwanted programs unavailable to the patients while locking the device in the needed relief setting. This way the patient does not receive the knowledge or ability to change the doctor's prescription settings without a clinician's consent. The OGYILI TENS/NMES Stimulator is programmed to default to program P- 14 which contains the most common setting. The device gives the clinician ability to store frequencies or to choose from a set of many frequencies that allow quick and easy selection, for prescription of stimulation regimen that can be later stored in any of the many available memory slots. However once the program is set the patients does not have the ability to alter the program from what the doctor or licensed practitioner has deemed to be the most appropriate program for their patient's needs. The OGYILI TENS/NMES Stimulator has the following specifications: There is pulse mode with a bi-phase rectangular pulse frequency is 2Hz to 150Hz, the pulse width is 100-200 us. The power supply is DC 3.7-volt lithium battery. OGYILI TENS/NMES Stimulator package is comprised of the following items: - One TENS/NMES unit powered by DC 3.7-volt lithium battery ● - Two UL industry standard wires for electrodes conforming to FDA standards, ● - Four standard commercially available round 100 (mm) self adhesive electrodes. - One UL 110 battery rechargeable unit - Instruction manual. ● - Quick start instruction manual. ● - . Full package carrying case. The device has physical dimensions of 92 x 60 x 18 mm, and weighs 90 grams with battery.

The SMD-Sr90-DA Radionuclide Brachytherapy Source is indicated for episcleral brachytherapy. The SMD-Sr90-DA RBS device is intended for use within a manual brachytherapy applicator system.

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The UTAH CVX-RIPE™ is intended to mechanically improve the favorability of the cervix of pregnant patients at term gestation, in which induction of labor is medically indicated.

The UTAH CVX-RIPE™ is a double balloon catheter. The tip is placed through the vagina and into the cervical canal. The distal balloon is positioned against the internal cervical os and inflated with saline. The proximal balloon is positioned against the external cervical os and inflated with saline, providing gradual mechanical cervical dilation by simultaneously applying pressure on the internal and external cervical os. The materials used to manufacture the device, and which have patient contact, are all medical grade silicone. The UTAH CVX-RIPE™ consists of an 18 Fr., 42 cm silicone catheter with a silicone tip and two silicone balloons. Each balloon is independently inflated via a separate inflation lumen through color coded check valves located at the proximal end of the device. The check valves are marked accordingly, "U" for the distal uterine balloon and "V" for the proximal vaginal balloon. A malleable stainless steel stylet is included for ease of placement. The stylet is placed through a third separate lumen that is closed at the distal tip. The stylet is preloaded in the catheter.