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510(k) K923637

ARJO-CENTURY ARM AND LEG TANK SYSTEM by Arjo-Century, Inc. — Product Code ILJ

K923637 is an FDA 510(k) premarket notification submitted by Arjo-Century, Inc. for the device "ARJO-CENTURY ARM AND LEG TANK SYSTEM". The FDA issued a decision of Substantially Equivalent on February 12, 1993. The device falls under product code ILJ (Bath, Hydro-Massage), a Class II device regulated under 21 CFR 890.5100. Arjo-Century, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1993
Date Received
July 21, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bath, Hydro-Massage
Device Class
Class II
Regulation Number
890.5100
Review Panel
PM
Submission Type

Other clearances by Arjo-Century, Inc.

  • K930665 — CENTURY BATHING SYSTEM (August 28, 1995)
  • K926411 — SAF-LIFT/SAF-KARY (March 31, 1993)
  • K923617 — FULL MOVEMENT THERAPY SYSTEMS (November 9, 1992)
  • K923159 — ARJO-CENTURY PODIATRIC WHIRLPOOL SYSTEMS (August 6, 1992)
  • K920074 — ARJO CENTURY SCALES WITH REMOTE (April 6, 1992)

Other clearances for product code ILJ

  • K110994 — PARKER 500 (July 6, 2011)
  • K082951 — IMMERSION HYDROBATH (April 8, 2009)
  • K052479 — MBATH 1000 (60) (January 26, 2006)
  • K040772 — PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM (April 5, 2004)
  • K012061 — SUPERIOR BATH, MODEL 6300 (July 19, 2001)
  • K012057 — CASCADE BATH, MODEL 6900 (July 19, 2001)
  • K001079 — RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMO (May 1, 2000)
  • K993872 — VANNA BATHING SYSTEM (February 16, 2000)
  • K992779 — A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM (January 13, 2000)
  • K991184 — HYDROTONE-THERMAL CAPSULE SYSTEM (June 23, 1999)

FDA data resources