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510(k) K963409

POSEY HUGGER by J. T. Posey Co. — Product Code FMQ

K963409 is an FDA 510(k) premarket notification submitted by J. T. Posey Co. for the device "POSEY HUGGER". The FDA issued a decision of Substantially Equivalent on November 14, 1996. The device falls under product code FMQ (Restraint, Protective), a Class I device regulated under 21 CFR 880.6760. J. T. Posey Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 1996
Date Received
August 30, 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 J. T. Posey Co.

  • K113355 — POSEY BED (May 2, 2012)
  • K113357 — POSEY BED (March 21, 2012)
  • K103817 — POSEY BED (April 22, 2011)
  • K963436 — RESTRAINT ACCESSORIES (November 22, 1996)
  • K963410 — POSEY STRAIGHT JACKETS (November 22, 1996)
  • K963414 — MULTIPLE BELTS (November 22, 1996)
  • K963442 — JACKETS AND VESTS (November 22, 1996)
  • K963411 — POSEY LAPTOP TRAYS (November 19, 1996)
  • K963439 — PEDIATRIC LIMB HOLDERS (November 19, 1996)
  • K963437 — PELVIC HOLDERS (November 19, 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)
  • 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)

FDA data resources