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The BioWave BioWraps are cutaneous electrodes to be used with legally marketed BioWave branded neurostimulators. The knitted garment electrodes are non-sterile reusable prescription-use and OTC conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts include hand/wrist, elbow, foot/ankle, knee, and lower back.

The BioWave BioWraps are washable, wrappable bands made from a stretchable neoprene-like outer and silver fiber conductive inner fabric. The electrodes are secured to the skin through the wrapping of the bands. The BioWraps are intended for use on the hand/wrist, elbow, foot/ankle, knee, and lower back. When used alongside a conductive cream, the electrodes provide a low current density with uniform current distribution. The BioWraps are to be used alongside cleared BioWave neurostimulator devices (the BioWavePRO® RX (K052289), BioWaveHOME® RX (K152437), and BioWaveGO® OTC (K180943)).

The BioWaveGO Rx is indicated for prescription use for: · Symptomatic relief of chronic, intractable pain · Symptomatic relief of acute pain · As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain

The BioWaveGO Rx Neuromodulation Pain Therapy Device is a battery-powered device intended to provide pain relief based on the technology of parent devices BioWaveHOME. The BioWaveGO Rx device delivers the summed high frequency alternating current sinusoidal signals between electrodes, providing symptomatic relief of acute, chronic, and post-operative pain. The device is identical in design to the BioWaveGO cleared in K180943. However, this 510(k) seeks clearance of the device for prescription use. The BioWaveGO Rx has the identical battery and software to the original clearance in K180943.

The BioWaveGO Neuromodulation Pain Therapy Device is indicated for: - Symptomatic relief of chronic, intractable pain - Symptomatic relief of acute pain - As an adjunctive treatment in the management of post-surgical and post-traumatic acute pain

The BioWaveGO Neuromodulation Pain Therapy Device is a battery-powered device intended to provide pain the technology of parent devices BioWavePRO. The key difference between the BioWaveGO and the parent device, the BioWaveHOME, is a reduced maximum voltage level, making the device available over-the-counter. The BioWaveGO device has a smaller battery system compared to the BioWaveGO device delivers the summed high frequency alternating current sinusoidal signals between electrodes, providing symptomatic relief of acute, chronic, and post-operative pain.

The BiowaveHOME Neuromodulation Pain Therapy Device is indicated for: - · Symptomatic relief of chronic, intractable pain, post-surgical and post-traumatic acute pain - · Symptomatic relief of acute pain - · Symptomatic relief of post-operative pain

The purpose of this Special 510(k) is to obtain clearance to market a modified version of the Homewaye Neuromodulation Pain Therapy Device (K072123). Biowaye Corporation's parent Homewave Neuromodulation Pain Therapy Device (K072123) is a TENS type device with a single optimized operational mode for the treatment of pain. Biowaye has made some minor modifications to the Homewaye Neuromodulation Device resulting in the proposed BiowaveHOME device. The minor modifications involve the following: - . BiowaveHOME has a newer more advanced power supply, two lithium iron phosphate batteries, that will last longer between charges and can sustain approximately 3 times the number of charge/discharge cycles versus Homewave's three lithium ion batteries. Lithium iron phosphate rechargeable batteries are also safer than lithium ion with respect to overheating and over or under charging issues. - . BiowaveHOME utilizes a larger custom LCD display with larger characters making it much easier to read the intensity and count down timer and other information as compared to Homewave. - . BiowaveHOME has a PAUSE button added to the face of the device giving the patient an obvious choice to pause or stop the treatment if necessary. - . BiowaveHOME has a smaller more ergonomic form factor making it easier to hold and move about as compared to Homewave. The modified BiowaveHOME Neuromodulation Pain Therapy Device has the identical intended use, indications and functionality as the original Homewave Neuromodulation Pain Therapy Device described in K072123.

The Homewave Neuromodulation Pain Therapy Device is indicated for: - . Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic acute pain - Symptomatic relief of acute pain . - Symptomatic relief of post-operative pain .

The purpose of this Special 510(k) is to obtain clearance to market a modified version of the Deepwave Neuromodulation Pain Therapy Device (K052289) and the Deepwave PENS Neuromodulation Pain Therapy Device (K061166). The parent Biowave Deepwave Neuromodulation Pain Therapy Device (K052289) and Biowave Deepwave PENS Neuromodulation Pain Therapy Device (K061166) have indications for use that are the same as TENS and interferential stimulation devices. Biowave has made some minor modifications to the Deepwave Neuromodulation Device resulting in a safer and easier-to-use device for the end-user (called the Homewave device). The minor modifications are as the follows: - Homewave has a smaller power supply (lithium ion polymer rechargeable . battery) that will last approximately 3 hours vs. 8 hours for Deepwave) - . Homewave includes a custom connector at the end of the electrode that houses an electronic integrated circuit ("chip"). The Homewave device checks the electronic chip when the electrode is attached to the leadwires, and the leadwires to the device. The electronic chip limits the use of the pad to 5 twenty-minute treatments or 100 minutes of total use. - . Treatment time is fixed for Homewave at 20 minutes vs. adjustable between 5-60 minutes for Deepwave. The modified Homewave Neuromodulation Device has the identical intended use, indications and functionality as the original Deepwave Neuromodulation Device described in K052289 and the Deepwave PENS Neuromodulation Pain Therapy Device described in K061166.

The Deepwave Percutaneous Neuromodulation Pain Therapy System is comprised of a percutaneous electrode array and the Deepwave Neuromodulation Pain Therapy Device. The Deepwave Percutaneous Neuromodulation Pain Therapy System is indicated for: - Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic acute pain; - Symptomatic relief of post-traumatic pain; - Symptomatic relief of post-operative pain.

Biowave Corporation's Deepwave Percutaneous Neuromodulation Pain Therapy System is essentially identical to Biowave's Deepwave Neuromodulation Pain Therapy Device cleared under K052289 except that the proposed device includes a percutaneous electrode array instead of standard surface electrodes. The percutaneous electrode array (PEA) is a sterile, single-use microneedle patch which facilitates the delivery of electrical signals through the skin into tissue. The size of the PEA patch is 2.5 inches in diameter. In the center of the patch is a 1.5 inch diameter array of 1014 microneedles made from medical grade 316L stainless steel which are 736 microns (0.736 millimeters) in length. When placed onto the skin the PEA feels like sandpaper or Velcro to the touch. The Feed Pad is a standard electrode that is 2" x 4" or 5" x 8" in size. The Deepwave Percutaneous Neuromodulation device sends a signal from the Feed Pad through the body to the PEA. The Deepwave Percutaneous Neuromodulation Pain Therapy Device is a batterypowered device intended to provide clinicians with the ability to prescribe PENS therapy. The device measures approximately 7.4 inches wide, 5.6 inches long, and 2.25 inches deep, weighs about 3 pounds, and operates on a 12 volt rechargeable NiMH battery that is enclosed within the unit. The unit will not operate while it is plugged into the wall to recharge the battery. The patient controls the amplitude of the signal with two buttons (a Plus (+) Button and a Minus (-) Button) on the face of the device. An LCD displays the amplitude of the signal in numerical format. Two wires emanate from the unit. One wire is attached to a large disposable electrode pad placed opposite the source of pain ("Feed Pad"). The second wire is attached to a smaller microneedle patch called a Percutaneous Electrode Array ("PEA") placed directly over the source of the pain (the treatment site).

The Deepwave Neuromodulation Pain Therapy Device is indicated for: - Symptomatic relief of chronic, intractable pain, post surgical and post-traumatic . acute pain; - Symptomatic relief of post-traumatic acute pain . - Symptomatic relief of post-operative pain .

The Biowave Corporation Neuromodulation Pain Therapy Device is a battery-powered device intended to provide clinicians with the flexibility to prescribe powered muscle stimulation and TENS therapy. The device measures approximately 7.4 inches wide, 5.6 inches long, and 2.25 inches deep, weighs about 3 pounds, and operates on a 12 volt rechargeable NiMH battery that is enclosed within the unit. The unit will not operate while it is plugged into the wall to recharge the battery. The patient controls the amplitude of the signal with two buttons (a Plus (+) Button and a Minus (-) Button) on the face of the device. An LCD displays the amplitude of the signal in numerical format. Two wires emanate from the unit. One wire is attached to a large disposable electrode pad placed opposite the source of pain ("Feed Pad"). The second wire is attached to a smaller electrode pad ("Pain Site Pad") placed directly over the source of the pain (the treatment site).