The following data is part of a premarket notification filed by Btl Industries, Inc. with the FDA for Hpm-6000.
| Device ID | K160992 |
| 510k Number | K160992 |
| Device Name: | HPM-6000 |
| Classification | Stimulator, Muscle, Powered |
| 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 | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-08 |
| Decision Date | 2016-10-21 |
| Summary: | summary |