The following data is part of a premarket notification filed by Tactile Systems Technology Inc with the FDA for Biotouch Massage Therapy System.
| Device ID | K013061 |
| 510k Number | K013061 |
| Device Name: | BIOTOUCH MASSAGE THERAPY SYSTEM |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | TACTILE SYSTEMS TECHNOLOGY INC 1074 LEGION ST. Shakopee, MN 55379 |
| Contact | Eric Mckee |
| Correspondent | Eric Mckee TACTILE SYSTEMS TECHNOLOGY INC 1074 LEGION ST. Shakopee, MN 55379 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-11 |
| Decision Date | 2002-07-01 |
| Summary: | summary |