The following data is part of a premarket notification filed by Tactile Systems Technology Inc (dba Tactile Medical) with the FDA for Flexitouch System.
| Device ID | K153311 |
| 510k Number | K153311 |
| Device Name: | Flexitouch System |
| Classification | Sleeve, Head And Neck, Compressible |
| Applicant | TACTILE SYSTEMS TECHNOLOGY INC (DBA TACTILE MEDICAL) 1331 Tyler St NE, Ste 200 Minneapolis, MN 55413 |
| Contact | Thomas A Dold |
| Correspondent | Thomas A Dold TACTILE SYSTEMS TECHNOLOGY INC (DBA TACTILE MEDICAL) 1331 Tyler St NE, Ste 200 Minneapolis, MN 55413 |
| Product Code | PPS |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-17 |
| Decision Date | 2016-09-14 |
| Summary: | summary |