The following data is part of a premarket notification filed by Bio-medical Research, Ltd. with the FDA for Slendertone Flex Bottom & Thigh Toning System, Type 511.
Device ID | K022855 |
510k Number | K022855 |
Device Name: | SLENDERTONE FLEX BOTTOM & THIGH TONING SYSTEM, TYPE 511 |
Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
Applicant | BIO-MEDICAL RESEARCH, LTD. 700 13TH ST. NW SUITE 1200 Washington, DC 20005 |
Contact | Robert A Dormer |
Correspondent | Robert A 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 | 2002-08-27 |
Decision Date | 2003-03-06 |
Summary: | summary |