The following data is part of a premarket notification filed by Btl Industries, Inc. with the FDA for Hpm-6000u.
| Device ID | K162010 |
| 510k Number | K162010 |
| Device Name: | HPM-6000U |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| 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 | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-20 |
| Decision Date | 2016-12-13 |
| Summary: | summary |