Cleared Traditional

DENOVO TEDDY GEL INFANT HEEL WARMER

K103549 · Denovo Products, LLC · Physical Medicine

Apr 2011

Decision

126d

Days

Class 1

Risk

About This 510(k) Submission

K103549 is an FDA 510(k) clearance for the DENOVO TEDDY GEL INFANT HEEL WARMER, a Infant Heel Warmer (chemical Heat Pack) (Class I — General Controls, product code MPO), submitted by Denovo Products, LLC (Fort Myers, US). The FDA issued a Cleared decision on April 8, 2011, 126 days after receiving the submission on December 3, 2010. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5710.

Submission Details

510(k) Number	K103549 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 03, 2010
Decision Date	April 08, 2011
Days to Decision	126 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement