The following data is part of a premarket notification filed by Dk Electronics, Llc with the FDA for Flowkeepers.
Device ID | K160323 |
510k Number | K160323 |
Device Name: | FlowKeepers |
Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
Applicant | DK ELECTRONICS, LLC 413-B ELMWOOD AVE, Sharon Hill, PA 19079 |
Contact | Avery Huff |
Correspondent | Avery Huff DK ELECTRONICS, LLC 413-B ELMWOOD AVE, Sharon Hill, PA 19079 |
Product Code | NGX |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-02-05 |
Decision Date | 2017-04-06 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FLOWKEEPERS 75501750 2482822 Live/Registered |
MEDAHEAD, INC. 1998-06-15 |