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510(k) K854263

SETMA FHT, MODEL ST 8130 by Setma, Inc. — Product Code ILJ

K854263 is an FDA 510(k) premarket notification submitted by Setma, Inc. for the device "SETMA FHT, MODEL ST 8130". The FDA issued a decision of Substantially Equivalent on November 13, 1985. The device falls under product code ILJ (Bath, Hydro-Massage), a Class II device regulated under 21 CFR 890.5100. Setma, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 1985
Date Received
October 23, 1985
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 Setma, Inc.

  • K854861 — SETMA HYGIA BATH MODEL ST 7200 (January 3, 1986)
  • K853163 — SETMA VHT (November 5, 1985)
  • K841397 — BURN BATH (May 18, 1984)
  • K841395 — SHOWER TROLLEY (May 7, 1984)
  • K841398 — VARIABLE HEIGHT TRANSFER CHAIR (May 7, 1984)
  • K841396 — TRANSFER TROLLEY (May 7, 1984)

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