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510(k) K150627

Rapid Aid Instant Disposable Infant Heel Warmer by Rapid Aid Corp. — Product Code MPO

K150627 is an FDA 510(k) premarket notification submitted by Rapid Aid Corp. for the device "Rapid Aid Instant Disposable Infant Heel Warmer". The FDA issued a decision of Substantially Equivalent on May 27, 2015. The device falls under product code MPO (Infant Heel Warmer (Chemical Heat Pack)), a Class I device regulated under 21 CFR 890.5710. Rapid Aid Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 2015
Date Received
March 11, 2015
Clearance Type
Special
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 by Rapid Aid Corp.

  • K163295 — Infant Transport Mattress Warmer with Disc (July 24, 2017)
  • K040856 — RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER (May 3, 2004)

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)
  • K103549 — DENOVO TEDDY GEL INFANT HEEL WARMER (April 8, 2011)
  • 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