Data / Medical devices / United States / Tactile Systems Technology Inc
Tactile Systems Technology Inc: FDA-registered device maker in New Brighton, MN, United States, 7 510(k) clearances
Tactile Systems Technology Inc is registered with the FDA (registration 3004183730) in New Brighton, MN, United States. It lists 3 device types. The FDA files 7 510(k) clearances under its listings, the newest dated April 30, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004183730
- Address
- 151 5th Ave NW Suite 100, New Brighton, MN, United States, 55112
- Owner or operator
- TACTILE SYSTEMS TECHNOLOGY INC (9056600)
- Roles
- Manufacturer
- First device listed
- November 4, 2015
- Registered through
- 2026
- Brand names listed
- AffloVest, Entre Model PD08-U, Entre Plus Model PD08-NG, Flexitouch Plus, Flexitouch Plus Bluetooth, Flexitouch Plus Comfort Ease, Flexitouch System, Flexitouch System Model PD32-G3 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Percussor, Powered-Electric | BYI | 2 | Manufacturer | accessdata.fda.gov |
| Sleeve, Head And Neck, Compressible | PPS | 2 | Manufacturer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 30, 2026 | K252849 | AffloVest® Mobile Airway Clearance Therapy | BYI | Substantially Equivalent | Tactile Medical | accessdata.fda.gov |
| June 21, 2024 | K234155 | Nimbl (model PD08-N1) | JOW | Substantially Equivalent | Tactile Medical | accessdata.fda.gov |
| December 20, 2020 | K203178 | Flexitouch Plus System | JOW | Substantially Equivalent | Tactile Systems Technology, Inc. (Dba Tactile Medical) | accessdata.fda.gov |
| May 26, 2017 | K170216 | Flexitouch System | JOW | Substantially Equivalent | Tactile Systems Technology, Inc. (Dba Tactile Medical) | accessdata.fda.gov |
| September 14, 2016 | K153311 | Flexitouch System | PPS | Substantially Equivalent | Tactile Systems Technology, Inc. (Dba Tactile Medical) | accessdata.fda.gov |
| May 7, 2015 | K143185 | entré Model PD08-U | JOW | Substantially Equivalent | Tactile Systems Technology, Inc. | accessdata.fda.gov |
| March 27, 2013 | K122480 | INTERNATIONAL BIOPHYSICS CORPORATION AFFLOVEST | BYI | Substantially Equivalent | International Biophysics Corporation | accessdata.fda.gov |
Compare with other makers
Updated April 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.