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510(k) K971592

XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM by The Silcraft Corp. — Product Code ILJ

K971592 is an FDA 510(k) premarket notification submitted by The Silcraft Corp. for the device "XTANK2 MOBILE EXTREMITY WHIRLPOOL SYSTEM". The FDA issued a decision of Substantially Equivalent on February 26, 1998. The device falls under product code ILJ (Bath, Hydro-Massage), a Class II device regulated under 21 CFR 890.5100. The Silcraft Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 26, 1998
Date Received
May 1, 1997
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 The Silcraft Corp.

  • K971593 — SILCRAFT ACCESS 3700 WHIRLPOOL SYSTEM, SILCRAFT MODEL 1800 LIFT, SILCRAFT DISINF (February 26, 1998)

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