The following data is part of a premarket notification filed by Btl Industries, Inc. with the FDA for Tr-100.
| Device ID | K161551 |
| 510k Number | K161551 |
| Device Name: | TR-100 |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | BTL INDUSTRIES, INC. 47 LORING DRIVE Framingham, MA 01702 |
| Contact | Jan Zarsky |
| Correspondent | Jan Zarsky BTL INDUSTRIES, INC. 47 LORING DRIVE Framingham, MA 01702 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-03 |
| Decision Date | 2016-09-13 |
| Summary: | summary |