Home / 510(k) Clearances / K841397

510(k) K841397

BURN BATH by Setma, Inc. — Product Code ILJ

K841397 is an FDA 510(k) premarket notification submitted by Setma, Inc. for the device "BURN BATH". The FDA issued a decision of Substantially Equivalent on May 18, 1984. 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
May 18, 1984
Date Received
April 3, 1984
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)
  • K854263 — SETMA FHT, MODEL ST 8130 (November 13, 1985)
  • K853163 — SETMA VHT (November 5, 1985)
  • K841398 — VARIABLE HEIGHT TRANSFER CHAIR (May 7, 1984)
  • K841395 — SHOWER TROLLEY (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