The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Slendertone Flex Max, Model 517 Us.
Device ID | K100556 |
510k Number | K100556 |
Device Name: | SLENDERTONE FLEX MAX, MODEL 517 US |
Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
Applicant | BIO-MEDICAL RESEARCH, LTD. BMR HOUSE PARKMORE BUSINESS PARK, WEST Galway, IE |
Contact | Anne-marie Keenan |
Correspondent | Anne-marie Keenan BIO-MEDICAL RESEARCH, LTD. BMR HOUSE 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 | 2010-03-01 |
Decision Date | 2010-08-02 |
Summary: | summary |