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510(k) K103549

DENOVO TEDDY GEL INFANT HEEL WARMER by Denovo Products, LLC — Product Code MPO

K103549 is an FDA 510(k) premarket notification submitted by Denovo Products, LLC for the device "DENOVO TEDDY GEL INFANT HEEL WARMER". The FDA issued a decision of Substantially Equivalent on April 8, 2011. The device falls under product code MPO (Infant Heel Warmer (Chemical Heat Pack)), a Class I device regulated under 21 CFR 890.5710.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2011
Date Received
December 3, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Infant Heel Warmer (Chemical Heat Pack)
Device Class
Class I
Regulation Number
890.5710
Review Panel
PM
Submission Type

Other clearances for product code MPO

  • K221154 — Infant Heel WarmerTM; Heel Snuggler® (October 7, 2022)
  • K151845 — Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) (March 18, 2016)
  • K150627 — Rapid Aid Instant Disposable Infant Heel Warmer (May 27, 2015)
  • K053254 — INFANT HEEL WARMER BY INTCO (September 19, 2006)
  • K040856 — RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER (May 3, 2004)
  • K040044 — HEEL SNUGGLER, MODEL 99047 (January 27, 2004)
  • K032989 — MEDI-HEAT INFANT HEEL WARMER (October 22, 2003)
  • K964523 — RECOVER INFANT HEEL WARMER (5100) (February 10, 1997)
  • K961154 — BAXTER SODIUM ACETATE INFANT HEEL WARMER (June 6, 1996)
  • K954716 — DEROYAL INDUSTRIES INFANT HEEL WARMER (January 11, 1996)

FDA data resources