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Funhaler is intended for use primarily in the pediatric population. Funhaler is used in combination with a Metered Dose Inhaler for respiratory drug delivery.

The Funhaler® V201 is basically a Spacer, similar in function and construction to commonly used Spacers. It is nearly identical and functionally equivalent to the predicate device (Funhaler®, Infamed Ltd; K042546) the device consists of a Mouthpiece, cylindrical Spacer. tapered on each end, incentive module and a molded connector compatible with approved Metered Dose Inhalers.

Funhaler® is intended for use primarily in the pediatric population. Pediatric subgroups may vary, however Funhaler® is suitable to all subgroups with the exception of newborns and infants younger than 18 months. Funhaler® is used in combination with a Metered Dose Inhaler for respiratory drug delivery. Funhaler® is primarily intended for use in the pediatric population in conjunction with prescribed Metered Dose Inhalers for their respective approved uses in accordance with physician instructions. Funhaler® is for prescription use only. Funhaler® is only indicated for use with Metered Dose Inhalers. Other products such as Nebulizers and Actuators are not suitable for use with Funhaler®. Funhaler® is intended to improve compliance with pediatric patients in the use of MDI's, by providing audible and visual feedback to the patient indicating the proper use of the MDI and resultant medication delivery to the patient.

The Funhaler® is basically a Spacer, similar in function and construction to commonly used Spacers such as the predicate device (Optichamber®, Respironics, Inc; K962822) and others, such as CT Spacer (K010680). The device consists of a Mouthpiece, cylindrical Spacer, tapered on each end and a molded connector compatible with approved Metered Dose Inhalers. The Funhaler® differs from predicate device in a number of ways; - 1. Funhaler® is provided with a breathing Mask in addition to the Mouthpiece. The breathing mask fits over the face (mouth and nose) to assure the full inhalation of the drug from the MDI in pediatric patients. Older (larger) patients may use the Mouthpiece in lieu of the Mask. - 2. Funhaler® incorporates a Whistle to provide audible feedback when the Spacer is used properly with the MDI, aiding in compliance with children. - 3. Funhaler® incorporates a Spinner Disk, having a Mylar sticker, which spins and provides visual feedback (by spinning) when the Spacer is used properly with the MDI, also aiding in compliance with children. The Funhaler® works in conjunction with virtually all standard, approved, Metered Dose Inhalers and has been tested for particle size, distribution and drug delivery with a variety of MDI's and drugs in accordance with FDA Guidance for these devices.