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510(k) K962038

PES HOT/COLD COMPRESS by Princeton Electronic Systems, Inc. — Product Code IRT

K962038 is an FDA 510(k) premarket notification submitted by Princeton Electronic Systems, Inc. for the device "PES HOT/COLD COMPRESS". The FDA issued a decision of Substantially Equivalent on November 13, 1996. 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
November 13, 1996
Date Received
May 24, 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 for product code IRT

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  • 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