The following data is part of a premarket notification filed by Tactile Systems Technology Inc with the FDA for Flexitouch System.
| Device ID | K120972 |
| 510k Number | K120972 |
| Device Name: | FLEXITOUCH SYSTEM |
| Classification | Sleeve, Limb, Compressible |
| Applicant | TACTILE SYSTEMS TECHNOLOGY INC 1331 Tyler St NE Ste 200 Minneapolis, MN 55413 |
| Contact | Phillip Rose |
| Correspondent | Ned Devine UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-04-02 |
| Decision Date | 2012-04-13 |
| Summary: | summary |