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510(k) K963528

ALIMED POSITIONING 7 SAFETY STRAPS (THREE TYPES), UNIVERSAL CR/MRI WIDE BODY STRAP, UNIVERSAL CT SCANNER STRAP (2 SIZES) by Alimed, Inc. — Product Code FMQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1996
Date Received
September 4, 1996
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 Alimed, Inc.

  • K963527 — UNIVERSAL ECONO-STRAP, QUALCRAFT UNIVERSAL STRAPS (October 31, 1996)
  • K963526 — STRAP WEDGE (October 28, 1996)
  • K920487 — MINI VIBRATOR (February 18, 1992)
  • K840156 — PROTECTA COAT SPONGES (March 23, 1984)
  • K822650 — SUPER DONUT (September 30, 1982)
  • K822651 — TOTAL FINGER FLEXION SPLINT (September 17, 1982)
  • K820516 — ARTERIAL CANALIZATION DEVICE (April 15, 1982)
  • K820517 — CONSTRUCTA FOAM (March 10, 1982)
  • K801743 — PLASTAZOTE SHOE (August 7, 1980)
  • K791189 — ECHO CARDIOGRAM PAD (July 17, 1979)

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)
  • 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)