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510(k) Data Aggregation
K Number
K073334Device Name
OHMNISCAN NG
Manufacturer
Date Cleared
2008-08-22
(268 days)
Product Code
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
CHRISTINE VALMY INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Ohmnsiscan NG is a non prescription device and is used on healthy subjects with no known disease or condition, and is identified as used for generally healthy adults (18-65). It is used to estimate the following:
- Impedance(Z in ohms) .
- Total body water (TBW in L and in %) .
- Lean Mass(LM in KG) .
- Fat Mass (FM in KG and %) .
- Basal Metabolism(Kcal) .
- Daily energy needs(Kcal) ●
- B.M.I. (Body Mass Index). .
Device Description
Ohmniscan NG is a high performance portable bioimpedance measuring device that enables evaluation of daily energy needs, fat mass (in % of total weight and in kg), lean mass (in kg) hydric condition (in % of total weight and in kg), body mass index, using a painless micro current technique.
It is used for the initial assessment and for treatment monitoring. Regular check allows fat loss to be monitored and the results are used as a highly motivational tool.
Ohmniscan NG releases a very low intensity alternating current at a 50 KHz frequency, by applying the four polar methods to measure the body resistance. This measurement determines the client's impedance.
Ohmniscan NG enables the creation of 100 customer cards with upto 8 measurements of the customer, their records, the interpretations, and the comparison between 2 measurements of the same client. It enables the creation of a customer file with surname, first name, sex, race, age, height, weight, activity, date of measurement, interpretation, and comparisons. Its fast measuring function allows calculations to be made in a minimum amount of time and they can be interpreted later. The unit comes complete with pen, connection wires and electrodes. The device is delivered with printer for ticket results.
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