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510(k) K905629

PEDICRAFT INFANT REFLUX WEDGE by Pedicraft, Inc. — Product Code FRP

K905629 is an FDA 510(k) premarket notification submitted by Pedicraft, Inc. for the device "PEDICRAFT INFANT REFLUX WEDGE". The FDA issued a decision of Substantially Equivalent on March 13, 1991. The device falls under product code FRP (Holder, Infant Position), a Class I device regulated under 21 CFR 880.5680. Pedicraft, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1991
Date Received
December 14, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Infant Position
Device Class
Class I
Regulation Number
880.5680
Review Panel
HO
Submission Type

Other clearances by Pedicraft, Inc.

  • K925949 — PEDICRAGT BASSINET (April 20, 1993)
  • K925817 — HEAD & FOOT END DROP PEDI-CRIB (April 20, 1993)
  • K905630 — INFANT REFLUX SLING (March 13, 1991)
  • K821773 — PEDICRAFT BED, MODEL B2944 (June 23, 1982)

Other clearances for product code FRP

  • K082367 — INFANT SLEEP BEANIE (June 12, 2009)
  • K090284 — RES-Q INFANT WEDGE AND SLING (June 5, 2009)
  • K062143 — KOZY COMFORT INFANT POSITIONER (October 24, 2006)
  • K060986 — HEAD BED (July 11, 2006)
  • K051300 — ROBIN HOOD VEST (December 8, 2005)
  • K041996 — NIGHTFORM (August 3, 2004)
  • K003511 — KENDALL-LTP TURNER SAVE-A-LINE (January 24, 2001)
  • K943017 — NEONATAL RESTRAINT AND COMFORT SYSTEMS (January 19, 1995)
  • K932636 — THE TUCKER SLING (January 26, 1994)
  • K905630 — INFANT REFLUX SLING (March 13, 1991)

FDA data resources