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510(k) K991184

HYDROTONE-THERMAL CAPSULE SYSTEM by Nats Corp. — Product Code ILJ

K991184 is an FDA 510(k) premarket notification submitted by Nats Corp. for the device "HYDROTONE-THERMAL CAPSULE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 23, 1999. The device falls under product code ILJ (Bath, Hydro-Massage), a Class II device regulated under 21 CFR 890.5100. Nats Corp. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1999
Date Received
April 8, 1999
Clearance Type
Abbreviated
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 Nats Corp.

  • K040143 — MONORAIL (September 13, 2004)
  • K033142 — POWERED WHEELCHAIR (May 19, 2004)
  • K020060 — ASTOFLO (March 5, 2002)
  • K011820 — DENTORIUM CONVERTIBLE ACRYLIC (September 5, 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)
  • 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)
  • K980909 — VICHY SHOWER (August 11, 1998)

FDA data resources