The following data is part of a premarket notification filed by Bio-medical Research Corp. with the FDA for Slendertone System Abs, Models 390, E10, X10; Slendertone System Shorts, Models 390, E20.
Device ID | K070142 |
510k Number | K070142 |
Device Name: | SLENDERTONE SYSTEM ABS, MODELS 390, E10, X10; SLENDERTONE SYSTEM SHORTS, MODELS 390, E20 |
Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
Applicant | BIO-MEDICAL RESEARCH CORP. PARKMORE BUSINESS PARK WEST Galway, IE |
Contact | Anne-marie Keenan |
Correspondent | Anne-marie Keenan BIO-MEDICAL RESEARCH CORP. PARKMORE BUSINESS PARK WEST Galway, IE |
Product Code | NGX |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-01-16 |
Decision Date | 2007-03-23 |
Summary: | summary |