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510(k) K220514

bite away neo by mibeTec GmbH — Product Code IRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2022
Date Received
February 22, 2022
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 mibeTec GmbH

  • K250047 — bite away two (September 12, 2025)

Other clearances for product code IRT

  • K250047 — bite away two (September 12, 2025)
  • 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)
  • K962252 — HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4 (November 25, 1996)