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510(k) K823154

SHOWER STOOL W/HANDLES by Orthion Corp. — Product Code IKX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 1982
Date Received
October 20, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aid, Transfer
Device Class
Class I
Regulation Number
890.5050
Review Panel
PM
Submission Type

Other clearances by Orthion Corp.

  • K832546 — MARK V HIGH VOLTAGE GALVANIC STIMULATORR (October 14, 1983)
  • K823151 — OB TRIPP TRANSPORT CHAIR (November 5, 1982)
  • K823153 — BATH TUB SEAT & BATH BOARD (November 5, 1982)
  • K823155 — LAVATORY SEAT HEIGHTENER (November 5, 1982)
  • K823156 — COLLAPSABLE LAVATORY HEIGHTENER (November 5, 1982)
  • K823149 — OB TILT TABLE (November 5, 1982)
  • K823152 — OB HELP ARM (November 5, 1982)
  • K823105 — RESI-WALKER (November 5, 1982)
  • K823150 — SESAM TREATMENT TABLE (November 5, 1982)
  • K812701 — ORTHO-THERM INFRARED SENSOR (October 13, 1981)

Other clearances for product code IKX

  • K862895 — TRICYCLES (August 13, 1986)
  • K842650 — WALL GRAB BARS 98130-98136 (August 10, 1984)
  • K831541 — TUB TRANSFER BENCH BK6481 (June 2, 1983)
  • K823640 — BATH TUB SAFETY BAR (January 21, 1983)
  • K823639 — BOARD TO TRANSFER PARALYZED PATIENT FROM (January 21, 1983)
  • K823634 — CHAIR OR BED LEG EXTENDERS (December 28, 1982)
  • K823153 — BATH TUB SEAT & BATH BOARD (November 5, 1982)
  • K821903 — DISC-O-AID (July 20, 1982)
  • K821010 — BATHTUB TRANSFER BENCH (April 21, 1982)
  • K813629 — BK-6111 HI-D TRANSFER BOARD (January 19, 1982)