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The Provant Therapy System is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

The Provant Therapy System is nearly identical to the previously cleared Provant System Model 4201 (cleared under K091791), except for the device labeling. Specifically, unlike the Provant System Model.4201, the Provant Therapy System does not include a contraindication for use in patients with metal implants. The device includes a Control Unit and Treatment Applicator. Disposable Applicator Covers are provided for the Treatment Applicator for infection control and to provide appropriate contact surfaces for the patient. The Control Unit for the Provant Therapy System is housed in a UL-compliant injection-molded case made of high-impact ABS plastic. The case contains a lockable hinge to prevent accidental closure of the lid. Upon opening the Provant case, the user sees the control panel of the Control Unit. The main electronics of the Control Unit are housed beneath its control panel. The device also includes a Treatment Applicator that is attached to the Control Unit. When not in use, the Treatment Applicator is stored inside the carrying case. The Treatment Applicator is removed from the case prior to administration of therapy, inserted into a Disposable Applicator Cover, and placed directly over the area to be treated. Device labeling is also located inside the case cover. Four pre-drilled holes in the underside of the case allow for attachment of the device to the optional roller stand (sold separately). The Disposable Applicator Covers of the Provant Therapy System are single-use-only and are intended to minimize contagion and help protect the Treatment Applicator from biological contamination. The Disposable Applicator Covers contain a Radio Frequency Identification Device (RFID) tag which guards against reuse of used Disposable Applicator Covers.

The Provant System is intended for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

Much like the predicate Regenesis Model 42 device, the new Provant System includes a Control Unit and Treatment Applicator. Disposable Applicator Covers are provided for the Treatment Applicator for infection control and to provide appropriate contact surfaces for the patient. The predicate Provant System contains the same components. The Control Unit for the Provant System is housed in a UL-compliant injection-molded case made of high-impact ABS plastic. The case contains a lockable hinge to prevent accidental closure of the lid. Upon opening the Provant case, the user sees the control panel of the Control Unit. The main electronics of the Control Unit are housed beneath its control panel. The device also includes a Treatment Applicator that is attached to the Control Unit. When not in use, the Treatment Applicator is stored inside the carrying case. The Treatment Applicator is removed from the case prior to administration of therapy, inserted into its Disposable Applicator Cover, and placed directly over the area to be treated. Device labeling is also located inside the case cover. Four pre-drilled holes in the underside of the case allow for attachment of the device to the optional roller stand (sold separately). The Disposable Applicator Covers of the Provant System are single-use-only and are intended to minimize contagion and help protect the Treatment Applicator from biological contamination. The Disposable Applicator Covers contain a Radio Frequency Identification Device (RFID) tag which guards against reuse of used Disposable Applicator Covers.

The Regenesis Model 42 is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.

The Regenesis Model 42 device is a pulsed short-wave diathermy device. The device has a solid state design that is very simple. It has no microprocessor and therefore no software. The Regenesis Model 42 unit consists of a main control console connected by cable to a treatment pad. The pad and cable are a single unit which is connected or disconnected easily from the console. The pad surface is water proof, bacterial resistant and designed to be placed directly on the patient or on top of any standard dressings used over the area to be treated.