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510(k) K103817

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

K103817 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 April 22, 2011. 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
April 22, 2011
Date Received
December 29, 2010
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.

  • K113355 — POSEY BED (May 2, 2012)
  • K113357 — POSEY BED (March 21, 2012)
  • 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)
  • K963413 — MULTIPLE LIMB HOLDERS (November 14, 1996)

Other clearances for product code OYS

  • K113355 — POSEY BED (May 2, 2012)
  • K113357 — POSEY BED (March 21, 2012)

FDA data resources