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 |