The following data is part of a premarket notification filed by Transamerica Medical Systems with the FDA for Transamerica Digital Ems.
| Device ID | K010665 |
| 510k Number | K010665 |
| Device Name: | TRANSAMERICA DIGITAL EMS |
| Classification | Stimulator, Muscle, Powered |
| Applicant | TRANSAMERICA MEDICAL SYSTEMS 350 RACE ST. Holyoke, MA 01040 |
| Contact | John F Dunn |
| Correspondent | John F Dunn TRANSAMERICA MEDICAL SYSTEMS 350 RACE ST. Holyoke, MA 01040 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-03-06 |
| Decision Date | 2001-04-27 |