The following data is part of a premarket notification filed by Tactile Systems Technology Inc with the FDA for Actitouch Act-adaptive Compression Therapy System.
| Device ID | K131193 |
| 510k Number | K131193 |
| Device Name: | ACTITOUCH ACT-ADAPTIVE COMPRESSION THERAPY SYSTEM |
| Classification | Sleeve, Limb, Compressible |
| Applicant | TACTILE SYSTEMS TECHNOLOGY INC 1331 Tyler St NE Ste 200 Minneapolis, MN 55413 |
| Contact | Dave Halverson |
| Correspondent | Dave Halverson TACTILE SYSTEMS TECHNOLOGY INC 1331 Tyler St NE Ste 200 Minneapolis, MN 55413 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-26 |
| Decision Date | 2013-06-18 |
| Summary: | summary |