Home / 510(k) Clearances / K962195

510(k) K962195

HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3 by Sunbeam Health Division — Product Code IRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1996
Date Received
June 7, 1996
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 Sunbeam Health Division

  • K962252 — HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 (November 25, 1996)

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)
  • K962252 — HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 (November 25, 1996)