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510(k) K914125

FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403 by Ferno — Product Code ILJ

K914125 is an FDA 510(k) premarket notification submitted by Ferno for the device "FERNO ILLE HI-LO JR. MOBILE WHIRLPOOL, MODEL 403". The FDA issued a decision of Substantially Equivalent on October 25, 1991. The device falls under product code ILJ (Bath, Hydro-Massage), a Class II device regulated under 21 CFR 890.5100. Ferno has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1991
Date Received
September 13, 1991
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 Ferno

  • K932260 — FERNO-WASHINGTON AMBULANCE COT, 93ES SQUAD-MATE (September 9, 1993)
  • K931346 — FERNO-WASHINGTON INCUBATOR TRANSPORTER,# 29-IT (August 25, 1993)
  • K924669 — FERNO-WASHINGTON BASKET STRETCHER, MODEL 71-W (April 29, 1993)
  • K924023 — FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917 (April 14, 1993)

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