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510(k) K823154

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

K823154 is an FDA 510(k) premarket notification submitted by Orthion Corp. for the device "SHOWER STOOL W/HANDLES". The FDA issued a decision of Substantially Equivalent on November 5, 1982. The device falls under product code IKX (Aid, Transfer), a Class I device regulated under 21 CFR 890.5050. Orthion Corp. has at least 10 other 510(k) clearances on record.

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)
  • K823155 — LAVATORY SEAT HEIGHTENER (November 5, 1982)
  • K823153 — BATH TUB SEAT & BATH BOARD (November 5, 1982)
  • K823149 — OB TILT TABLE (November 5, 1982)
  • K823156 — COLLAPSABLE LAVATORY HEIGHTENER (November 5, 1982)
  • K823150 — SESAM TREATMENT TABLE (November 5, 1982)
  • K823152 — OB HELP ARM (November 5, 1982)
  • K823105 — RESI-WALKER (November 5, 1982)
  • K823151 — OB TRIPP TRANSPORT CHAIR (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)

FDA data resources