The following data is part of a premarket notification filed by Btl Industries, Inc. with the FDA for Btl-084.
| Device ID | K190023 |
| 510k Number | K190023 |
| Device Name: | BTL-084 |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | BTL Industries, Inc. 362 Elm Street Marlborough, MA 01752 |
| Contact | David Chmel |
| Correspondent | David Chmel BTL Industries, Inc. 362 Elm Street Marlborough, MA 01752 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-04 |
| Decision Date | 2019-03-29 |