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510(k) K052479

MBATH 1000 (60) by Enneking Medical, Inc. — Product Code ILJ

K052479 is an FDA 510(k) premarket notification submitted by Enneking Medical, Inc. for the device "MBATH 1000 (60)". The FDA issued a decision of Substantially Equivalent on January 26, 2006. The device falls under product code ILJ (Bath, Hydro-Massage), a Class II device regulated under 21 CFR 890.5100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 2006
Date Received
September 9, 2005
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 for product code ILJ

  • K110994 — PARKER 500 (July 6, 2011)
  • K082951 — IMMERSION HYDROBATH (April 8, 2009)
  • 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)
  • K980909 — VICHY SHOWER (August 11, 1998)

FDA data resources