Foot Baths & Hand Massagers

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K810034 ↗

FDA Product Code

ILJ

Device Class

Class II

Regulation

21 CFR Part 890.5100

Advisory Committee

Physical Medicine

FDA Decision

SESE Substantially Equivalent

• BP800, 850 1000

  Class II

  FDA 510(k) K841095 Active Cleared 24 Aug 1984

• Whirlpool Aerator WB700, WB800, WB900, WB975

  Class II

  FDA 510(k) K872327 Active Cleared 4 Sep 1987

• Hp-20, 30, 40, 50 & 60

  Class II

  FDA 510(k) K841100 Active Cleared 23 Mar 1984

• WM10, WM20, WM30 Power Massager

  Class I

  FDA 510(k) K862041 Active Cleared 17 Jun 1986

• SH20, SH30 & SH50 Ultrasonic Humidifier

  Class I

  FDA 510(k) K862042 Active Cleared 5 Jun 1986

• Pollenex Digital Thermometer T-225

  Class II

  FDA 510(k) K850363 Active Cleared 15 Feb 1985

See all devices from Associated Mills, Inc. →

• What is the Foot Baths & Hand Massagers device used for?

  The device is intended for use in physical medicine to provide hydrotherapy and massage functions for therapeutic purposes, as classified under Bath, Hydro-Massage.

• Is the Foot Baths & Hand Massagers device reusable or single-use?

  The device is supplied as a single-use item and is not reusable, meaning it is designed for one-time application and should be discarded after use.

• Is the Foot Baths & Hand Massagers device safe to use in an MRI environment?

  The device is not MRI safe, so it should not be brought into or used near magnetic resonance imaging equipment due to potential safety risks.