The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Slendertone System Ultra Model E70/x70.
| Device ID | K100320 |
| 510k Number | K100320 |
| Device Name: | SLENDERTONE SYSTEM ULTRA MODEL E70/X70 |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK, WEST Galway, IE |
| Contact | Deirdre Barrow |
| Correspondent | Deirdre Barrow BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK, WEST Galway, IE |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-04 |
| Decision Date | 2010-05-05 |
| Summary: | summary |