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510(k) K010818

INFANT LIMB HOLDER, MODELS 306080 & 306081 by Skil-Care Corp. — Product Code FMQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2001
Date Received
March 19, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Restraint, Protective
Device Class
Class I
Regulation Number
880.6760
Review Panel
HO
Submission Type

Other clearances by Skil-Care Corp.

  • K010644 — CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 (May 18, 2001)
  • K963458 — PADDED MITTS/PADDED-PLUS MITTS/FINGER SEPARATOR PADDED MITTS/RIGID PALM PADDED M (October 18, 1996)
  • K963459 — SUPPORT VEST (October 15, 1996)
  • K963461 — SAFETY PONCHO/SHOULDER STRAP PONCHO (October 11, 1996)
  • K963460 — ROLL BELT (October 9, 1996)
  • K963457 — SLEEPER JACKET/HOUDINI SAFETY SLEEPER (October 9, 1996)
  • K963456 — LIMB HOLDERS-REUSABLE/LIMB HOLDERS-DISPOSABLE/QUICK-CUFF LIMB HOLDER (October 8, 1996)
  • K963455 — SLEEVED JACKET/SLEEVED JACKET WITH SLIDER CONTROL (October 8, 1996)
  • K963454 — CUSHION BELT/CUSHION SLIDER BELT/ADJUSTA-LOOP CUSHION BELT/QUICK RELEASE CUSHION (October 7, 1996)
  • K963447 — DOUBLE SUPPORT PONCHO/SLIDER PONCHO (October 7, 1996)

Other clearances for product code FMQ

  • K110377 — PROTECTIVE RESTRAINT (April 25, 2011)
  • K081264 — STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002 (February 13, 2009)
  • K080448 — CENTURION PROTECTIVE RESTRAINT, SCR SERIES (August 28, 2008)
  • K013239 — COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES (November 20, 2001)
  • K010644 — CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 (May 18, 2001)
  • K991591 — BIOTHANE PATIENT RESTRAINT (July 29, 1999)
  • K982178 — VAGABOND SOFT RESTRAINT SYSTEM (January 26, 1999)
  • K980640 — HEELBO WAIST AND CHEST VEST (May 1, 1998)
  • K972446 — PEDO CUSH PEDO CUDDLE (November 13, 1997)
  • K972046 — FULL BODY RESTRAINT SYSTEM (August 15, 1997)