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510(k) Data Aggregation
K Number
K073008Device Name
KFH ENERGY, MODEL: E1
Manufacturer
Date Cleared
2008-03-11
(139 days)
Product Code
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
KINGFISHER HEALTHCARE NV
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The KFH Energy device is indicated for the symptomatic relief of:
- Chronic Intractable Pain
- Post-Traumatic Pain
- Post-Surgical Pain
Device Description
The Kingfisher Healthcare NV KFH Energy model E1 is built in an ABS casing with controls and indicator integrated into a touch-sensitive opaque glass front panel, and designed to be comfortably held in the hand. The approximate dimensions of the unit are 190 x 80 x 30 mm and complete with batteries the unit weighs approximately 350 g (including batteries). The device is designed to deliver electric current in the range 300 to 600 microamperes at 100 Hz frequency to the body from four "AA" sized batteries (contained internally), for a predctermined time (30 or 60 minutes), through four adhesive skin electrodes (already found substantially equivalent through the 510(k) process). The output waveform is monophasic, rectangular with decay.
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