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510(k) K810034

FOOT BATHS & HAND MASSAGERS by Associated Mills, Inc. — Product Code ILJ

K810034 is an FDA 510(k) premarket notification submitted by Associated Mills, Inc. for the device "FOOT BATHS & HAND MASSAGERS". The FDA issued a decision of Substantially Equivalent on January 15, 1981. The device falls under product code ILJ (Bath, Hydro-Massage), a Class II device regulated under 21 CFR 890.5100. Associated Mills, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1981
Date Received
January 6, 1981
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 Associated Mills, Inc.

  • K901459 — DS60 TOOTHBRUSH SANITIZER (September 17, 1990)
  • K872327 — WHIRLPOOL AERATOR WB700, WB800, WB900, WB975 (September 4, 1987)
  • K871661 — WH150 ROOM HUMIDIFIER (June 15, 1987)
  • K862041 — WM10, WM20, WM30 POWER MASSAGER (June 17, 1986)
  • K862042 — SH20, SH30 & SH50 ULTRASONIC HUMIDIFIER (June 5, 1986)
  • K844397 — POLLENEX DIGITAL SPHYGMOMANOMETER BP-4000 (April 18, 1985)
  • K844396 — POLLENEX DIGITAL SPHYGMOMANOMETER BP-2000 (April 18, 1985)
  • K850362 — POLLENEX DIGITAL THERMOMETER T-125 (February 15, 1985)
  • K850363 — POLLENEX DIGITAL THERMOMETER T-225 (February 15, 1985)
  • K841095 — BP800, 850 1000 (August 24, 1984)

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