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510(k) K830852

SHOWER STOOL W/HANDLES by Lic-Orthion — Product Code ILS

K830852 is an FDA 510(k) premarket notification submitted by Lic-Orthion for the device "SHOWER STOOL W/HANDLES". The FDA issued a decision of Substantially Equivalent on April 5, 1983. The device falls under product code ILS (Adaptor, Hygiene), a Class I device regulated under 21 CFR 890.5050. Lic-Orthion has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1983
Date Received
March 17, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Adaptor, Hygiene
Device Class
Class I
Regulation Number
890.5050
Review Panel
PM
Submission Type

Other clearances by Lic-Orthion

  • K891649 — PATIENT EXAMINATION GLOVES (LATEX) (April 4, 1989)
  • K862022 — LIC-ORTHION MULTI-THERAPY TREATMENT TABLE (June 19, 1986)
  • K854730 — DAISY (ABSORBENT INCONTINENCE SHIELD) (February 6, 1986)
  • K854729 — ADAM (ABSORBENT INCONTINENCE SHIELD) (February 6, 1986)
  • K851471 — TRIBAG, TRIBAND & TRIFIX-REUSEABLE URINE COLLECTOR (June 12, 1985)
  • K851470 — BIBAG, BIBAND & BIFIX - SINGLE USE URINE COLLECTOR (June 12, 1985)
  • K843233 — ANATOM SYSTEM (October 25, 1984)
  • K843234 — CITOMAT AUTOCLAVES (October 25, 1984)
  • K830853 — LAVATORY SEAT HEIGHTENER (June 8, 1983)
  • K830855 — SESAM TREATMENT TABLE (April 5, 1983)

Other clearances for product code ILS

  • K852049 — MEDICAL TOILET SEAT (June 24, 1985)
  • K842651 — COMMODE CHAIR 98200 (August 7, 1984)
  • K831547 — RAISED TOILET SEATS & NAIL CLIPPERS (June 8, 1983)
  • K830853 — LAVATORY SEAT HEIGHTENER (June 8, 1983)
  • K830425 — TOILET SEAT RAISED (May 9, 1983)
  • K823641 — BATHING CHAIR FOR CHILD (January 21, 1983)
  • K823626 — DISPOSABLE TOOTH BRUSH (December 30, 1982)
  • K823606 — PLASTIC BREAK RESISTANT MIRROR (December 28, 1982)
  • K823156 — COLLAPSABLE LAVATORY HEIGHTENER (November 5, 1982)
  • K823155 — LAVATORY SEAT HEIGHTENER (November 5, 1982)

FDA data resources