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510(k) K923396

THERMODYN by Nemectron Medical, Inc. — Product Code IRT

K923396 is an FDA 510(k) premarket notification submitted by Nemectron Medical, Inc. for the device "THERMODYN". The FDA issued a decision of Substantially Equivalent on May 26, 1993. The device falls under product code IRT (Pad, Heating, Powered), a Class II device regulated under 21 CFR 890.5740. Nemectron Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 26, 1993
Date Received
July 10, 1992
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 Nemectron Medical, Inc.

  • K895000 — NEMECTRON MICROWAVE (July 27, 1990)
  • K862376 — NEMECTROSON MODEL 2 (July 23, 1986)
  • K854720 — NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM. (March 10, 1986)
  • K854721 — NEMECTRODYN MODEL 2 & ENDOVAC 2 (March 6, 1986)
  • K844416 — THERMOPULS E (March 12, 1985)
  • K843735 — SOFTEPIL (October 25, 1984)
  • K843734 — NEMDI (October 25, 1984)
  • K823511 — EMG BIOFEEDBACK DEVICE (March 31, 1983)
  • K820334 — NEMECTRODYN MODELS 8,7,5 (VOLS. I-IV (March 15, 1982)
  • K810513 — ELECTRODYN CII-INTERFERENTIAL MUSCLE (May 11, 1981)

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