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510(k) K010644

CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025 by Skil-Care Corp. — Product Code FMQ

K010644 is an FDA 510(k) premarket notification submitted by Skil-Care Corp. for the device "CINCH-TYPE DISPOSABLE LIMB HOLDERS, MODEL 912025". The FDA issued a decision of Substantially Equivalent on May 18, 2001. The device falls under product code FMQ (Restraint, Protective), a Class I device regulated under 21 CFR 880.6760. Skil-Care Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2001
Date Received
March 5, 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.

  • K010818 — INFANT LIMB HOLDER, MODELS 306080 & 306081 (May 24, 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)
  • K963457 — SLEEPER JACKET/HOUDINI SAFETY SLEEPER (October 9, 1996)
  • K963460 — ROLL BELT (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)
  • K963449 — PELVIC HOLDER (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)
  • K010818 — INFANT LIMB HOLDER, MODELS 306080 & 306081 (May 24, 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)

FDA data resources