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510(k) K113355

POSEY BED by J. T. Posey Co. — Product Code OYS

K113355 is an FDA 510(k) premarket notification submitted by J. T. Posey Co. for the device "POSEY BED". The FDA issued a decision of Substantially Equivalent on May 2, 2012. The device falls under product code OYS (Patient Bed With Canopy/Restraints), 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
May 2, 2012
Date Received
November 14, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Patient Bed With Canopy/Restraints
Device Class
Class I
Regulation Number
880.6760
Review Panel
HO
Submission Type

Enclosed bed canopy system used as passive restraint.

Other clearances by J. T. Posey Co.

  • K113357 — POSEY BED (March 21, 2012)
  • K103817 — POSEY BED (April 22, 2011)
  • K963442 — JACKETS AND VESTS (November 22, 1996)
  • K963436 — RESTRAINT ACCESSORIES (November 22, 1996)
  • K963414 — MULTIPLE BELTS (November 22, 1996)
  • K963410 — POSEY STRAIGHT JACKETS (November 22, 1996)
  • K963437 — PELVIC HOLDERS (November 19, 1996)
  • K963411 — POSEY LAPTOP TRAYS (November 19, 1996)
  • K963439 — PEDIATRIC LIMB HOLDERS (November 19, 1996)
  • K963409 — POSEY HUGGER (November 14, 1996)

Other clearances for product code OYS

  • K113357 — POSEY BED (March 21, 2012)
  • K103817 — POSEY BED (April 22, 2011)

FDA data resources