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510(k) Data Aggregation
K Number
K160323Device Name
FlowKeepers
Manufacturer
Date Cleared
2017-04-06
(426 days)
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
DK ELECTRONICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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 in the lower extremities (legs) due to strain from exercise, normal household duties and work activities.
Device Description
The FlowKeepers® is a portable, battery powered device and delivers electrical stimulation through the skin to the muscles. It provides low frequency (0.1 Hz) muscle stimulation with rectangular, bipolar, biphasic pulses, and operates in a range which balances between comfort and effective contractions. There is a control unit with power buttons and LED flasher.
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