Home / 510(k) Clearances / K823153

510(k) K823153

BATH TUB SEAT & BATH BOARD by Orthion Corp. — Product Code IKX

K823153 is an FDA 510(k) premarket notification submitted by Orthion Corp. for the device "BATH TUB SEAT & BATH BOARD". The FDA issued a decision of Substantially Equivalent on Nov 5, 1982. The device falls under product code IKX (Aid, Transfer), a Class I device regulated under 21 CFR 890.5050. Orthion Corp. has 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 5, 1982
Date Received
Oct 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
510(k) Exempt

Other clearances by Orthion Corp.

  • K832546 — MARK V HIGH VOLTAGE GALVANIC STIMULATORR (Oct 14, 1983)
  • K823150 — SESAM TREATMENT TABLE (Nov 5, 1982)
  • K823155 — LAVATORY SEAT HEIGHTENER (Nov 5, 1982)
  • K823149 — OB TILT TABLE (Nov 5, 1982)
  • K823152 — OB HELP ARM (Nov 5, 1982)
  • K823154 — SHOWER STOOL W/HANDLES (Nov 5, 1982)
  • K823156 — COLLAPSABLE LAVATORY HEIGHTENER (Nov 5, 1982)
  • K823105 — RESI-WALKER (Nov 5, 1982)
  • K823151 — OB TRIPP TRANSPORT CHAIR (Nov 5, 1982)
  • K812701 — ORTHO-THERM INFRARED SENSOR (Oct 13, 1981)

Other clearances for product code IKX

  • K862895 — TRICYCLES (Aug 13, 1986)
  • K842650 — WALL GRAB BARS 98130-98136 (Aug 10, 1984)
  • K831541 — TUB TRANSFER BENCH BK6481 (Jun 2, 1983)
  • K823640 — BATH TUB SAFETY BAR (Jan 21, 1983)
  • K823639 — BOARD TO TRANSFER PARALYZED PATIENT FROM (Jan 21, 1983)
  • K823634 — CHAIR OR BED LEG EXTENDERS (Dec 28, 1982)
  • K823154 — SHOWER STOOL W/HANDLES (Nov 5, 1982)
  • K821903 — DISC-O-AID (Jul 20, 1982)
  • K821010 — BATHTUB TRANSFER BENCH (Apr 21, 1982)
  • K813629 — BK-6111 HI-D TRANSFER BOARD (Jan 19, 1982)

FDA data resources