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Field Sales FDA Communication Update July

Dear valued Snug Seat supporter,

As you are by now aware, Snug Seat continues to operate with a FDA hold in place on approximately 35% of our pediatric rehab products.  In January of 2014 we had hoped that a summer release would be feasible,  however, due to FDA timelines, we have been faced with a longer than anticipated delay.   

We have recently been notified by the FDA that our documentation is complete and is now ready for final review and a re-visit to our manufacturing facility in Denmark. We now hope to have a final inspection by September and a lift of the FDA hold there to follow soon after. 

 I want to reiterate this hold is not product safety related and does not affect the majority of our products shipped in the US.  We continue to work diligently to fill all open orders and quotes as requested.  However, we do feel that to avoid any additional delays to your future orders, we ask that one of two things occur. 

First, only to utilize those products currently unaffected by the FDA hold, those are as follows:

All of the products  and related accessories below will continue to ship on an uninterrupted basis:

Mustang, Crocodile, x:panda, Caribou, Panda, High-low frames, Multi Frame, Strong Base, Gator, Pony, Bronco, Giraffe, Gecko, Minnow, Traveller Plus, Hippo, and Pilot. 

AND/OR

Second, For status of affected product inventory please contact Customer Service at 800-336-7684 to determine if the product is available before quote/order being placed.  We greatly appreciate your patience and support while we strive to better serve you during this short term delay.

The products currently on the FDA hold list are as follows:

Cougar, Panther, Cheetah, Flamingo, Stingray, Serval (Tiger 2000), Wombat, Nandu, Swan, Manatee, Rabbit, Buffalo, Gazelle, Toucan

We will be able to process orders for warranty and repair parts and accessories for the affected products.

Best Regards,

Scott Crosswhite, VP

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