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Buzzy® is intended to control pain associated with needle procedures (e.g., injections, vascular access, cannulation, lab draws, blood donation, dialysis, cosmetic and dental injections) and the temporary relief of minor injuries (muscle or tendon aches, splinters, and bee stings). VibraCool® is intended for the temporary relief of minor injuries (muscle or tendon aches) and the treatment of myofascial pain post-surgery. It is also indicated for use prior to or during physical therapy to treat myofascial pain caused by trigger points, restricted motion and muscle tension.

Buzzy® and VibraCool® devices are external use, skin contacting vibration devices that can be used with heat (for VibralCool® Flex, VibraCool® Pro UE and VibraCool® Pro LE)or cold therapy (for all Buzzy® and VibraCool® models) to provide pain relief. The brand names encompass the same two shapes of vibrating devices using the same motor. Buzzy Pro and VibraCool Pro are a new shape with the same motor submitted in this 510K. To accommodate various uses and anatomical locations, the Buzzy and VibraCool devices are available in three different shapes and are provided with different sets of accessories.

Control pain associated with injections, venipuncture, IV starts, cosmetic injections and the temporary relief of minor injuries (muscle or tendon aches, splinters and bee stings). Also intended to treat myofascial pain caused by trigger points, restricted motion and muscle tension

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