The following data is part of a premarket notification filed by Eprt Technologies, Inc. with the FDA for Bodihealth System.
| Device ID | K131675 |
| 510k Number | K131675 |
| Device Name: | BODIHEALTH SYSTEM |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | EPRT TECHNOLOGIES, INC. 468 N CAMDEN DRIVE SUITE 269C Beverly Hills, CA 90210 |
| Contact | Jeff Morgan |
| Correspondent | Jeff Morgan EPRT TECHNOLOGIES, INC. 468 N CAMDEN DRIVE SUITE 269C Beverly Hills, CA 90210 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-07 |
| Decision Date | 2014-03-12 |
| Summary: | summary |