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510(k) K040772

PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM by Penner Manufacturing, Inc. — Product Code ILJ

K040772 is an FDA 510(k) premarket notification submitted by Penner Manufacturing, Inc. for the device "PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM". The FDA issued a decision of Substantially Equivalent on April 5, 2004. The device falls under product code ILJ (Bath, Hydro-Massage), a Class II device regulated under 21 CFR 890.5100. Penner Manufacturing, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2004
Date Received
March 26, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Bath, Hydro-Massage
Device Class
Class II
Regulation Number
890.5100
Review Panel
PM
Submission Type

Other clearances by Penner Manufacturing, Inc.

  • K012061 — SUPERIOR BATH, MODEL 6300 (July 19, 2001)
  • K012057 — CASCADE BATH, MODEL 6900 (July 19, 2001)

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)
  • 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