FDA.reportPublic FDA data

TACTILE SYSTEMS TECHNOLOGY INC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30041837303004183730TACTILE SYSTEMS TECHNOLOGY INC1N2026-01-01151 5th Ave NW Suite 100 New Brighton MN US 55112

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
619541933589232K252849AffloVest® Mobile Airway Clearance TherapyBYI2026-04-30
619541090775453K234155Nimbl (model PD08-N1)JOW2024-06-21
619541795365778K203178Flexitouch Plus SystemJOW2020-12-20
619541812769945K170216Flexitouch SystemJOW2017-05-26
619542061179353K153311Flexitouch SystemPPS2016-09-14
619541497720754K143185entré Model PD08-UJOW2015-05-07
619541583835856K122480INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVESTBYI2013-03-27
619541387621375K103247VASCUCOMPJOW2010-12-10
619541756417791K071763AMADEUS ADAPTIVE COMPRESSION THERAPYJOW2008-03-07
619542034726395K013061BIOTOUCH MASSAGE THERAPY SYSTEMIRP2002-07-01
619541125623277

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JOW62024-06-21
BYI22026-04-30
PPS12016-09-14
IRP12002-07-01

PMN#

GUDID#

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