The following data is part of a premarket notification filed by Tactile Systems Technology Inc with the FDA for Flexitouch System.
| Device ID | K062818 |
| 510k Number | K062818 |
| Device Name: | FLEXITOUCH SYSTEM |
| Classification | Sleeve, Limb, Compressible |
| Applicant | TACTILE SYSTEMS TECHNOLOGY INC 4824 PARK GLEN RD. Minneapolis, MN 55416 |
| Contact | Phillip R Rose |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-09-20 |
| Decision Date | 2006-10-06 |
| Summary: | summary |