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510(k) K250047

Device
bite away two
Applicant
mibeTec GmbH
510(k) number
K250047
Product code
IRT
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-12
Date received
2025-01-10
Regulation
890.5740
Classification name
Pad, Heating, Powered
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Oliver Grunert
Address
Münchener St. 15 Brehna DE 06796 06796

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IRT#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220514bite away neomibeTec GmbH2022-06-23
K160943Bite AwayRiemser Pharma2016-08-26
K142228Heated Eye PadDigital Heat Corporation2015-02-09
K133981AVACEN 100Avacen, Inc.2014-08-15
K111273FIR HEAT THERAPHY SYSYEMSShenzhen Anpan Technology Co., Ltd.2011-11-08
K072534BIO-MAT 2000Richway Intl., Inc.2008-02-08
K963887PT-PAC PORTABLE HEATING PADAnthony A. Chiurco1997-03-31
K963824LI'S ITCH STOPPERHontech Foundation For Medical Technology1996-12-12
K962195HEALTH O METER ELECTRIC HEATING PADS MODELS EHP2, EHP3Sunbeam Health Division1996-11-27
K962252HEALTH O METER ELECTRIC HEATING PAD W/MASSAGE MODEL EHP4Sunbeam Health Division1996-11-25
K962038PES HOT/COLD COMPRESSPrinceton Electronic Systems, Inc.1996-11-13
K924970FEMININE HEAT WRAPConair Corp.1994-10-03
K925630ELASTOPLAST HEAT PLASTERBeiersdorf, Inc.1994-02-25
K925820ARTHRITIC HEAT WRAPConair Corp.1994-02-02
K924885KING SIZE HEAT PADConair Corp.1993-10-12