Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004183730

FEI Number

3004183730

Entity Name

TACTILE SYSTEMS TECHNOLOGY INC

City/State/Country

New Brighton, MN, US

Establishment Address

151 5th Ave NW Suite 100, New Brighton, MN 55112, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

TACTILE SYSTEMS TECHNOLOGY INC (Owner Number: 9056600)

Owner / Operator Contact Address

3701 Wayzata Blvd, Suite 300, Minneapolis, MN 55416, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K153311

PMA Number

N/A

All Registered Proprietary Names

AffloVest Flexitouch Plus Flexitouch Plus Comfort Ease Flexitouch Plus Bluetooth AffloVest Flexitouch System Model PD32-G3 Flexitouch Plus Entre Model PD08-U Entre Plus Model PD08-NG Flexitouch System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BYI	Percussor, Powered-Electric	Anesthesiology	Class 2	868.5665	2026-05-04
PPS	Sleeve, Head And Neck, Compressible	Cardiovascular	Class 2	870.5800	2021-02-22
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2021-02-22
BYI	Percussor, Powered-Electric	Anesthesiology	Class 2	868.5665	2022-05-02
PPS	Sleeve, Head And Neck, Compressible	Cardiovascular	Class 2	870.5800	2017-08-23
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2017-08-23
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2015-11-04
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2016-12-19
PPS	Sleeve, Head And Neck, Compressible	Cardiovascular	Class 2	870.5800	2016-12-19

Official Correspondent

Sunday Hoy

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

TACTILE SYSTEMS TECHNOLOGY INC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04

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2183816	HILL-ROM MANUFACTURING, INC.	SAINT PAUL, MN, US
3004961434	RESPIRATORY TECHNOLOGIES, INC.	Plymouth, MN, US
3023531666	Nextern Costa Rica Ltd.	Cartago, CR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004183730. Last updated year: 2026. Please use registration number 3004183730 when referencing this establishment in official correspondence.