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510(k) K133981

AVACEN 100 by Avacen, Inc. — Product Code IRT

K133981 is an FDA 510(k) premarket notification submitted by Avacen, Inc. for the device "AVACEN 100". The FDA issued a decision of Substantially Equivalent on August 15, 2014. 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
August 15, 2014
Date Received
December 26, 2013
Clearance Type
Abbreviated
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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  • K160943 — Bite Away (August 26, 2016)
  • K142228 — Heated Eye Pad (February 9, 2015)
  • 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)
  • K962252 — HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 (November 25, 1996)

FDA data resources