# K160323: FlowKeepers

- Pathway: 510(k) (Traditional)
- Applicant: Dk Electronics, LLC
- Decided: Apr 6, 2017 after 426 days
- Product code: NGX (Stimulator, Muscle, Powered, For Muscle Conditioning)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K940301 (1994). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143207: Revitive IX (OTC), Actegy, Ltd. (2015) Summary page 4.
- K140650: Hivox Electric Stimulator Otc Tens, Hivox Biotek, Inc. (2014) Summary page 4.

## Indications for use
Powered Muscle Stimulator - To temporarily increase local blood circulation in healthy leg muscles - To stimulate healthy muscles in order to improve and facilitate muscle performance TENS - For temporary relief of pain associated with sore and aching muscles of the lower extremities (legs) due to strain from exercise or normal household and work activities

Source page: https://510kreport.com/device/K160323
Methodology: https://510kreport.com/methodology