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510(k) K851237

THERMOPHORE ELECTRIC FOMENTATION UNIT by Battle Creek Equipment Co. — Product Code IRT

K851237 is an FDA 510(k) premarket notification submitted by Battle Creek Equipment Co. for the device "THERMOPHORE ELECTRIC FOMENTATION UNIT". The FDA issued a decision of Substantially Equivalent on July 29, 1985. The device falls under product code IRT (Pad, Heating, Powered), a Class II device regulated under 21 CFR 890.5740. Battle Creek Equipment Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1985
Date Received
March 27, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pad, Heating, Powered
Device Class
Class II
Regulation Number
890.5740
Review Panel
PM
Submission Type

Other clearances by Battle Creek Equipment Co.

  • K882264 — BATTLE CREEK PILLOW (August 9, 1988)
  • K863884 — PULSESTAR EXERCISE BIKE (October 23, 1986)
  • K854147 — BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL (December 27, 1985)
  • K854148 — BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL (December 17, 1985)
  • K840280 — ROAD RUNNER ELECTRIC TREADMILL (February 4, 1984)
  • K791866 — STANDARD HEALTH BIKE MODEL 019 (October 4, 1979)

Other clearances for product code IRT

  • K250047 — bite away two (September 12, 2025)
  • K220514 — bite away neo (June 23, 2022)
  • K160943 — Bite Away (August 26, 2016)
  • K142228 — Heated Eye Pad (February 9, 2015)
  • K133981 — AVACEN 100 (August 15, 2014)
  • K111273 — FIR HEAT THERAPHY SYSYEMS (November 8, 2011)
  • K072534 — BIO-MAT 2000 (February 8, 2008)
  • K963887 — PT-PAC PORTABLE HEATING PAD (March 31, 1997)
  • K963824 — LI'S ITCH STOPPER (December 12, 1996)
  • K962195 — HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3 (November 27, 1996)

FDA data resources