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 |