HomeUSATactile Systems Technology, Inc.

Tactile Systems Technology, Inc.

USA · New Brighton
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
3listed device types
Class I 0Class II 3Class III 0
plus 7 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
1active device licences
Class II 1
2 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States7 registration records, 8 510(k), 0 PMA, 5 excluded
Canada1 confirmed, 1 excluded
Manufacturer names merged into this page: TACTILE SYSTEMS TECHNOLOGY INC · TACTILE SYSTEMS TECHNOLOGY, INC. (DBA TACTILE MEDICAL)

Company information

Country
USA
City
New Brighton

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

Legal name
TACTILE SYSTEMS TECHNOLOGY INC
CIK
0001027838
Registration status
Active
Listing status
Listed (TCMD)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

12002
12006
12012
12013
12015
12016
12017
12020

FDA listed device types

Sleeve, Head And Neck, Compressible 1Sleeve, Limb, Compressible 1Percussor, Powered-Electric 1

Registration details (sample)

MarketIdentifierNameClass / date
USK203178Flexitouch Plus System2020-12-20
USK170216Flexitouch System2017-05-26
USK153311Flexitouch System2016-09-14
CA88415FLEXITOUCH SYSTEMClass II

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