The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Slendertone Gymbody, Model 512-01.
| Device ID | K052969 |
| 510k Number | K052969 |
| Device Name: | SLENDERTONE GYMBODY, MODEL 512-01 |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | BIO-MEDICAL RESEARCH, LTD. PARKMORE BUSINESS PARK WEST Galway, IE |
| Contact | Michael O'sullivan |
| Correspondent | Michael O'sullivan 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 | 2005-10-21 |
| Decision Date | 2005-11-16 |
| Summary: | summary |