The following data is part of a premarket notification filed by Btl Industries, Inc. with the FDA for Xp3000.
| Device ID | K150720 |
| 510k Number | K150720 |
| Device Name: | XP3000 |
| 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 | 2015-03-19 |
| Decision Date | 2015-09-16 |
| Summary: | summary |