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510(k) K160943

Bite Away by Riemser Pharma — Product Code IRT

K160943 is an FDA 510(k) premarket notification submitted by Riemser Pharma for the device "Bite Away". The FDA issued a decision of Substantially Equivalent on August 26, 2016. 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 26, 2016
Date Received
April 5, 2016
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)
  • 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)
  • K962252 — HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 (November 25, 1996)

FDA data resources