Field Sales FDA Communication Update Re-Inspection

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.

However, we were notified by the FDA that our documentation is complete and has passed final review. A re-visit to our manufacturing facility in Denmark has now been completed with no further observations we will need to address. With this knowledge, we now anticipate a release of the products on hold by the end of March, 2015 at the very latest.

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.


Second, For status of affected product inventory please contact Customer Service at 800-336-7684 to determine if 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. We greatly appreciate your patience throughout this untimely process.

Best Regards,

Scott Crosswhite, VP

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