The vast majority of women will qualify for use of the device, but of course women who are pregnant or have some types of serious mental conditions should not use the device. Directions for use of the Allay Period Relief Patch are thoroughly outlined in another section of this website and easy to follow directions are included in each package.
The control unit and the attached flexible loop are contained in a soft, hypo-allergenic, biodegradable sleeve. The sleeve containing the unit is placed next to the skin at the sight of edema swelling , pain, cramping or discomfort with most women simply tucking it into their panties.
The most comfortable position for most is to place the sleeve sideways, and many other women prefer to place the sleeve and up and down position. This maximum power output is maintained for at least hours, which allows for continuous use for three, five day periods. Of course, it is important to turn the unit off when not being used. Often times, the units will last even longer, but full power is only guaranteed for hours.
The red light on the control unit indicates the unit is functioning properly — when the light goes out simply discard the unit — it safe for normal disposal. The Allay Period Relief Patch should not be used by persons with a cardiac pacemaker, cardioverter defibrillator, neurostimulator or any active medical implant that is within the area of application, and of course, should not be used by any women who are pregnant or think she may be pregnant.
While the device is manufactured according to very strict FDA and international standards, it is not intended for use as a sterile device. If using near or over an open wound, cover the wound with sterile gauze prior to application.
While the sleeve that contains the device is manufactured from a dye-free, biodegradable hypoallergenic fabric, making skin irritation and likely, users should discontinue use if a rash or skin irritation develops and avoid using the product until a physician is consulted. It is also important not to stand, walk, or put the body weight on the unit as this may damage the circuitry.
Always consult a qualified healthcare practitioner to evaluate your condition prior to using this product. If pain, swelling or irritation persists or worsens, discontinue use and seek medical attention immediately. March 9, am. You'll find that it is safe, comfortable, government-approved, and easy to use. RecoveryRx, with its high degree of safety, excellent clinical evidence of effectiveness and exceptional cost-benefit, will become the standard of care.
Contact: Paul Knopick In addition to the data, the FDA requested an explanation on how the proposed analyses support the market clearance indication and precludes the need for any additional information.
Sree Koneru, Ph. The ActiPatch product is already FDA-cleared for over-the-counter adjunctive treatment of pain from knee osteoarthritis 25 million Americans and plantar fasciitis 2 million Americans annually. In the back pain study that was submitted to the FDA as clinical evidence, the ActiPatch was found to have a significant treatment effect in women, but only a mild treatment effect in men.
The medical community acknowledges that there are gender differences in responses to pain therapies [1], and importantly, that women experience pain more intensely than men [2]. Moreover, women are at a greater risk of using opioids than men to combat chronic pain [3]. Gender-level analysis of the prior ActiPatch clinical data revealed that there indeed were differences in treatment effects between men and women, with women reporting more pain relief than men.
The company intends to leverage these findings and resubmit the k application for a more specific indication: relief of musculoskeletal pain for women. Sree Koneru, VP of Product Development, expressed confidence in this strategy, both from a regulatory and marketability perspective. The Maryland Daily Record reports: The Allay patch consists of a computerized microchip and battery connected to a flexible loop, which are contained in a sleeve worn against the skin.
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