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510(k) K922089

PNEUMATHERM by National Pain Institute — Product Code IRT

K922089 is an FDA 510(k) premarket notification submitted by National Pain Institute for the device "PNEUMATHERM". The FDA issued a decision of Substantially Equivalent on February 23, 1993. The device falls under product code IRT (Pad, Heating, Powered), a Class II device regulated under 21 CFR 890.5740.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1993
Date Received
May 4, 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 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