The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Slendertone Flex, Model, 512.
| Device ID | K010335 |
| 510k Number | K010335 |
| Device Name: | SLENDERTONE FLEX, MODEL, 512 |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | BIO-MEDICAL RESEARCH, LTD. 700 13TH ST. NW SUITE 1200 Washington, DC 20005 |
| Contact | Robert Dormer |
| Correspondent | Robert Dormer BIO-MEDICAL RESEARCH, LTD. 700 13TH ST. NW SUITE 1200 Washington, DC 20005 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-02 |
| Decision Date | 2001-09-27 |