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510(k) K992779

A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM by Medi-Man Rehabilitation Products, Inc. — Product Code ILJ

K992779 is an FDA 510(k) premarket notification submitted by Medi-Man Rehabilitation Products, Inc. for the device "A-2000 BATHING SYSTEMS; HYDROSONIC BATHIN SYSTEM". The FDA issued a decision of Substantially Equivalent on January 13, 2000. The device falls under product code ILJ (Bath, Hydro-Massage), a Class II device regulated under 21 CFR 890.5100. Medi-Man Rehabilitation Products, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2000
Date Received
August 18, 1999
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 Medi-Man Rehabilitation Products, Inc.

  • K925195 — MALIBU BATHING SYSTEM (October 17, 1994)
  • K924905 — MEDI-PLINTH (February 16, 1993)
  • K844976 — MEDI-MAN WATER POWERED BATH LIFT & HYDRAULIC LIFT (April 1, 1985)

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)
  • K991184 — HYDROTONE-THERMAL CAPSULE SYSTEM (June 23, 1999)
  • K980909 — VICHY SHOWER (August 11, 1998)

FDA data resources